Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1923569

FEI Number

1923569

Entity Name

STERIS Corporation

City/State/Country

Saint Louis, MO, US

Establishment Address

5 SUNNEN DR., Saint Louis, MO 63143, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STERIS (Owner Number: 10091086)

Owner / Operator Contact Address

5960 Heisley Rd, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

V. Mueller Bone File Bayonet (WM-RR) V. Mueller Bone File (ST-CFE) V. Mueller Ear Currette (ST-CFE,SD, WM-FE,RR) Sterilization Process Indicator (CL-RR, ST-CFE) Snowden-Pencer Fiberoptic Retractor (ST-MF) V. Mueller Forceps (WM-FE,RR) Snowden-Pencer Forceps (ST-MF, WM-FE,RR) V. Mueller Guide Needle (ST-CFE) V. Mueller Endoscopic Kittner (ST-CFE) V. Mueller Ear Hook (ST-MF, WM-FE,RR) V. Mueller Lefort Urethral (ST-MF) V. Mueller Jewett Urethral (ST-MF) V. Mueller Van Buren Urethral (ST-MF) V. Mueller McCrea Female Sound (ST-MF) V. Mueller Campbell Miniature (ST-SD, WM-RR,FE) V. Mueller Otis Urethral (ST-SD, WM-RR, FE) V. Mueller Ophthalmic Cannula (ST-MF) V. Mueller Ventricular Cannula (ST-MF) V. Mueller Knot Tier/Pusher (ST-CFE) V. Mueller Vaginal Retractor (ST-MF,SD, WM-FE,RR) V. Mueller ENT Knife (ST-SD, WM-FE,RR) V. Mueller Roberts Cotton Applicators (ST-MF) V. Mueller X-ray Detectable Sponges (ST-CFE) Snowden-Pencer MIS (ST-CFE) V. Mueller Color Plate Microsurgical Tray (ST-CFE) V. Mueller Uterine Sound (ST-MF, WM-FE,RR) V. Mueller Bipolar Forceps (ST-RR) V. Mueller Trephine (ST-CFE, WM-FE,RR) V. Mueller Nail Nippers (ST-RR,WM-FE,RR) (OS3063, SA15100, SA15110, SA15120, SA15132) V, Mueller Nail Nippers (WM-FE, RR) (SU15085, SU15100, SU15110, SU15120, SU15130, SU15131) V. Mueller Lead Hand Malleable (ST-SD, WM-FE,RR) V. Mueller Instrument Tray (ST-CFE,SD) V. Mueller Open (ST-CFE) Snowden-Pencer Markers (ST-SD, WM-FE,RR) Snowden-Pencer Diamond Flex Graspers (ST-MF,RR) V. Mueller Retractor (ST-MF, WM-FE,RR) V. Mueller Screwdriver (ST-CFE) V. Mueller Cystotome (ST-CFE) Snowden-Pencer Forceps (ST-RR,SD, WM-FE,RR) V. Mueller Tissue Forceps (ST-RR,SD, WM-FE,RR) V. Mueller Nasal Currette (ST-SD, WM-FE,RR) V. Mueller Corkscrew (ST-CFE) V. Mueller VERRES NEEDLE (ST-CFE) V. Mueller Ophthalmic Knife (ST-MF, SD, WM-FE,RR) Snowden-Pencer Needle Holder (ST-SD, WM-FE,RR) V, Mueller Needle Holder (ST-SD, WM-FE,RR) V. Mueller Awl (ST-CFE) V. Mueller Elevator (ST-MF, WM-FE,RR) V. Mueller Pliers (ST-CFE, WM-FE,RR) V. Mueller Cutting Board and Blocks (ST-MF) Snowden-Pencer Diamond Flex Graspers (ST-MF,RR) V. Mueller Hirschman Anoscope (ST-SD, WM-FE, RR) V. Mueller Insufflation Tubing (ST-CFE) V. Mueller Lap Calibrated Probe (ST-MF,RR) Affinity Scissors (ST-RR, WM-FE,RR) V. Mueller Scissors (ST-RR, WM-FE,RR) V. Mueller Grasping Devices (ST-RR) V. Mueller Genesis Containers (CL-MF,RR, ST-SD) V. Mueller Cardiovascular Surgical Instrument (ST-MF,RR , WM-FE,RR) Snowden-Pencer Cardiovascular Surgical Instrument (ST-MF,RR, WM-FE,RR) V. Mueller Endontia Rongeur (ST-CFE) V. Mueller Neuro/Spine SPETZLER HEADREST SYSTEM SET (ST-RR,MF) V. Mueller Pin Skull (ST-MF,RR) V. Mueller Mallet (ST-SD, WM-FE,RR) Genesis Container Systems (CL-MF,RR, ST-SD) V. Mueller Urethographic Catherer (ST-CFE,SD) V. Mueller Elevator (WM-FE,RR) Snowden-Pencer Elevator (ST-MF, WM-FE,RR) V. Mueller ENT Elevator (ST-MF, WM-FE,RR) V. Mueller Lempert Currette (WM-FE,RR) V. Mueller Comedo Extractor (WM-FE,RR) V. Mueller Currettes (ST-MF, WM-FE) Ergonomic Take Apart (ST-MF, RR, WM-FE,RR) Snowden-Pencer (ST-MF,RR, WM-FE,RR) V. Mueller Genesis Low Temperature Reusable Rigid Container System (CL-RR, MF, ST-SD) V. Mueller Drill and Saw (ST-SD, WM-FE, RR) V. Mueller Mouth Gag (ST-SD, WM-FE,RR) Snowden-Pencer Surgical Scissors (ST-MF, WM-FE,RR) V. Mueller Surgical Scissors (ST-MF, WM-FE,RR) V. Mueller Urethral Dilator (ST-SD, WM-FE,RR) Snowden-Pencer Dental Currette (ST-SD, WM-FE, RR) V. Mueller ENT Retractor (ST-MF, WM-FE,RR) V. Mueller Punch (WM-FE,RR) V. Mueller Ophthalmic Hook (ST-MF, WM-FE,RR) V. Mueller Stripper (ST-SD, WM-FE, RR) V. Mueller Open (ST-CFE) V. Mueller Tonsil Dissector (ST-MF) V. Mueller Bone Tamp (ST-MF) V. Mueller Needle Holder (ST-SD, WM_FE,RR) Snowden-Pencer Columella Clamp (ST-SD, WM-RR) V. Mueller Micro Scissors (ST-MF, WM-FE,RR) V. Mueller Fixation Ring (ST-SD, WM-FE,RR) V. Mueller ENT Speculum (ST-SD, WM-FE,RR) Snowden-Pencer Ergonomic Reposable Scissors (ST-SD, CFE) V. Mueller Open Retractors (ST-CFE) V. Mueller Perforator (ST-MF, WM-FE,RR) V. Mueller Suture Puller (ST-CFE) V. Mueller Nasal Chisel (ST-MF, WM-FE,RR) V. Mueller Ear Knife (ST-MF, WM-FE,RR) V. Mueller Neuro/Spine (ST-MF) V. Mueller Currette (WM-FE,RR) V. Mueller Measuring Ear Rod (ST-MF) Affinity Metric Ruler (ST-RR) V. Mueller Caliper and Measure Gages (ST-RR) Affinity Uterine Packer (ST-SD,CFE, WM-FE,RR) V. Mueller Genesis Reusable Sterilization Container System (CL-MF, ST-SD) V. Mueller Tonsil Snare (ST-RR, WM-FE,RR) V. Mueller Otis Bougie (ST-MF) Snowden-Pencer Knife Handles (ST-MF) V, Mueller Knife Blades (ST-MF) V. Mueller Retractor (ST-RR) V. Mueller Oral Elevators (ST-CFE) V. Mueller Dialator Probe (ST-SD, WM-FE,RR) V. Mueller Uterine Currette (ST-CFE, WM-FE,RR) V. Mueller Ear PIck (ST-MF, WM-FE,RR) V. Mueller Obstetrical Forceps (ST-SD, WM-FE,RR) V. MUELLER ENT Forceps (WM-FE,RR) Snowden-Pencer ENT Forceps (WM-FE,RR) V. Mueller Micro Wire Crimper (ST-CFE) V. Mueller Lapcare Silicone Tray (ST-CFE) V. Mueller 6-position Slotted Sterilization Cassette (ST-CFE) V. Mueller Freeman Areola Marker (ST-CFE) V. Mueller Opticare Universal Scope, Shallow & Light Cable Trays (ST-CFE) V. Mueller Modultainer Container, Mat, Lid, Base (ST-CFE) V. Mueller Minitainer Tray with Mat (ST-CFE) V. Mueller Opticare Arthroscope Tray (ST-CFE) V. Mueller Cast Spreader and Remover (ST-RR, WM-FE,RR) V. Mueller Neuro/Spine VERSA-TRAC (ST-RR, WM-FE) V. Mueller Neuro/Spine Shadow-Line (ST-RR, WM-FE,RR) V. Mueller Retraction and Distraction Platforms (ST-MF,RR, WM-FE,RR) V. Mueller Ophthalmic Forceps (ST-SD, WM-FE,RR) V. Mueller Suction Tube (ST-MF, WM-FE,RR) V. Mueller Hibbs Bone Chisel (ST-MF) V. Mueller Clamps (ST-SD, WM-FE,RR) V. Mueller Neuro/Spine (ST-MF) V. Mueller Bipolar Forceps (ST-RR) Snowden-Pencer MIS (ST-SD,CFE) Snowden-Pencer Rasp (ST-MF, WM-FE, RR) Snowden-Pencer MIS (ST-CFE) V. Mueller ENT Probe (ST-MF, WM-FE,RR) V. Mueller Caliper (ST-MF, WM-FE,RR) V. Mueller Bipolar Forceps (ST-RR) V. Mueller Cosgrove Clamps (ST-MF,RR) V. Mueller Ophthalmic Specula (ST-SD, WM-FE,RR) V. Mueller Vaginal Specula (ST-SD, WM-FE,RR) V. Mueller Oral Extracting Forceps (ST-CFE) V. Mueller Biopsy Forceps, Rayport Muscle Biopsy Clamp (ST-MF) V. Mueller Yeomans Biopsy Forceps & Price Muscle Biopsy Clamp (ST-SD, WM-RR,FE) V. Mueller Ophthalmic Spoon Currette (ST-SD, WM-FE,RR) V. Mueller Currettte (ST-CFE,SD, WM-FE,RR) V. Mueller Neuro/Spine Spatula (ST-CFE) V. Mueller Liston Amputation Knife Blade (ST-CFE) V. Mueller Ear Cannula (ST-CFE,SD) V. Mueller Vascular Dilator (ST-CFE) V. Mueller Lachrymal Probe (ST-CFE,SD) V. Mueller Nasal Knife (ST-MF, WM-FE,RR) V. Mueller Biopsy Needle (ST-CFE) V. Mueller Corneo-Scleral Punch (ST-CFE) V. Mueller Ear Suction Tube (ST-MF, WM-FE,RR) V. Mueller Neuro/Spine VERSA-TRAC (CL-RR, ST-RR) V. Mueller Retraction and Distraction Platforms (CL-RR, ST-MF,RR) V. Mueller Neuro/Spine Shadow-Line (CL-RR, ST-SD) V. Mueller Foreign Body Spud (ST-CFE,SD, WM-FE,RR) V. Mueller Penile Clamp (ST-MF, WM-FE,RR) V. Mueller Basket Tag (CL-RR, ST-MF) V. Mueller Color Plate (CL-RR, ST-MF) V. Mueller Jeweler, Rhoton,Forceps & Scissors (WM-FE,RR) V. Mueller Neuro/Spine (ST-RR) Snowden-Pencer Scissors (WM-FE,RR) V. Mueller Garrett Vascular Dilator (ST-MF) V. Mueller Uterine Cannula (ST-MF,RR) Genesis Container Systems (CL-RR, ST-SD, CFE) V. Mueller Instrument Care Emesis Basin (CL-RR, ST-CFE) V. Mueller Suction Instruments (ST-MF) Snowden-Pencer Saw Loop (ST-CFE, WM-FE, RR) V. Mueller Saw Blades (ST-CFE, WM-FE,RR) Snowden-Pencer Scissors (WM-FE,RR) Snowden-Pencer Diamond-Line (ST-MF,RR, WM-FE,RR) V. Mueller Bipolar Forceps (ST-RR) V. Mueller Orthopaedic Cottle Hammer (ST-MF, WM-FE,RR) Snowden-Pencer Orthopaedic Cottle Hammer (WM-FE,RR) V. Mueller Magill Forceps (WM-FE,RR) V. Mueller Chest Tube Passer (ST-CFE) V. Mueller Impactor (ST-MF) V. Mueller Forceps (ST-RR , WM-FE,RR) Affinity Forceps (ST-RR) Snowden Pencer Forceps (WM-FE, RR) V. Mueller Probe (ST-MF) V. Mueller Bunnell Dissecting Probe (ST-SD) V. Mueller Rhoton Straight Point Needle (ST-MF) V. Mueller Skin Hook (ST-MF, WM-FE,RR) Snowden-Pencer Skin Hook (ST-MF, WM-FE,RR) V. Mueller Orthopedic Shears (ST-CFE, WM-CFE,RR) V. Mueller Nasal Rongeur (ST-CFE, WM-FE,RR) Snowden-Pencer Needle Holder (ST-MF, WM-FE,RR) V. Mueller Needle Holder (ST-SD, WM-FE,RR) V. Mueller Orthopedic Tray (ST-SD,CFE) V. Mueller Ear Scissors (ST-SD, WM-FE,RR) V. Mueller STAMEY Needle (ST-CFE) SNOWDEN PENCER FAST CLAMP (ST-MF) V. Mueller Dental Arch Bar (ST-CFE) Snowden-Pencer MIS Closed End Knot Pusher (ST-RR) V. Mueller Ear Snare (ST-CFE, WM-FE,RR) V. Mueller Ear Loop (ST-MF, WM-FE,RR) V. Mueller ENT Punch (ST-RR, WM-FE,RR) Snowden-Pencer MIS (ST-CFE) V. Mueller Umbilibal Scissors (ST-SD,CFE) V. Mueller High Frequency Cord (ST-CFE) Snowden Pencer Hemostat (ST-CFE, WM-FE,RR) V. Mueller Affinity Hemostat (ST-CFE, WM-FE,RR) V. Mueller Nasal Saw (ST-CFE, WM-FE,RR) Snowden-Pencer Nasal Saw (ST-CFE, WM-FE,RR) V. Mueller Fogarty Hydragrip Vascular Clamps (ST-MF) V. Mueller Fogarty Spring Vascular Clamp (ST-RR) V. Mueller MIS (ST-CFE) V. Mueller Tracheal Dilator (ST-SD, WM-FE,RR) V. Mueller Neuro/Spine Rongeur (ST-SD, WM-FE, RR) V. Mueller Rongeur (ST-SD, WM-FE, RR) Snowden-Pencer Osteotome Chisel (WM-FE,RR) V. Mueller Osteotome Chisel (ST-SD) V. Mueller Storage Rack (ST-SD) V. Mueller Retractor Trays (ST-CFE, SD) V. Mueller Orthopedic Knife (ST-MF) V. Mueller Scalpel Handle (ST-MF, WM-FE,RR) V. Mueller Shadow-Line Color Coded Gauge (ST-MF) V. Mueller Wiet Stapedotomy (ST-MF) V. Mueller Scoope (ST-MF, WM-FE,RR) V. Mueller Eye Needle Holder (ST-SD, WM-FE,RR) V. Mueller Nasal Scissiors (ST-SD, WM-FE,RR) Snowden-Pencer Osteotomes (ST-RR) V. Mueller Osteotomes (ST-RR) V. Mueller Rhoton Retractor (ST-MF,RR) V. Mueller Drill Bit (ST-CFE) V. Mueller Gouge (ST-MF) V. Mueller Fistula Probe (ST-MF) V. Mueller Instrument Tip Protector (ST-MF) Snowden-Pencer Forceps (WM-FE,RR) V. Mueller Needle Holder (ST-MF, WM-FE,RR) V. Mueller Bone Hooks (ST-MF, WM-FE,RR) V. Mueller Surgical Hammer (ST-CFE) V. Mueller Removable Hook (ST-CFE) V. Mueller Ophthalmic Caliper (ST-CFE,SD, WM-FE,RR) V. Mueller Ligature Carriers & Needles (ST-MF, WM-FE,RR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2024-07-11
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-06-27
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2024-07-01
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-09-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-08-22
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2024-07-01
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
HCD	Cannula, Ventricular	Neurology	Class 1	882.4060	2024-07-01
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2025-07-28
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2024-07-01
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2024-07-01
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2025-07-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-08-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-06-27
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HWK	Trephine	Orthopedic	Class 1	888.4540	2024-07-10
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-11
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-07-11
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2025-08-13
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2025-08-11
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2024-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-01
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2024-07-01
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2025-08-16
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2025-08-13
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
HWI	Corkscrew	Orthopedic	Class 1	888.4540	2025-08-16
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2025-09-13
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2024-07-11
HWJ	Awl	Orthopedic	Class 1	888.4540	2025-08-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-07-01
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-11
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2024-07-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-01
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2024-07-10
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2025-08-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-07-01
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-07-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-27
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-06-27
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2024-07-01
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-07-19
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2024-07-01
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2024-07-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-06-27
FGI	Catheter, Urethrographic, Male	Gastroenterology, Urology	Class 2	876.5130	2024-07-01
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-01
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-06-27
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2024-07-11
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-01
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2024-07-11
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2024-07-11
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2024-07-10
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2025-08-13
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
HXG	Tamp	Orthopedic	Class 1	888.4540	2024-07-01
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2024-07-01
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2024-07-11
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2024-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-27
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2025-07-27
EIG	Retractor, All Types	Dental	Class 1	872.4565	2025-07-19
KAT	Perforator, Antrum	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-07-27
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2024-07-01
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2024-07-01
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HDM	Packer, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2024-07-10
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-06-27
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2024-07-01
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2025-07-28
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2025-07-19
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2024-07-10
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-07-10
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2024-07-10
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2025-08-11
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2025-08-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-06-27
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2024-07-10
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2024-07-01
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-10
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-06-27
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2024-07-10
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2024-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-08-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2025-07-27
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-08-22
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
KTZ	Caliper	Orthopedic	Class 1	888.4150	2024-07-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-01
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-07-01
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-11
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2024-07-10
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2025-07-19
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-07-01
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-10
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2024-07-11
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-07-27
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2025-07-27
JYC	Cannula, Ear	General, Plastic Surgery	Class 1	878.4800	2025-08-17
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2025-08-18
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2025-08-20
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2024-07-01
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2025-08-20
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2024-06-27
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-10
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2024-07-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-06-27
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2024-07-01
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2024-07-01
HES	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)	Obstetrics/Gynecology	Class 2	884.1300	2024-07-01
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-06-27
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2024-06-27
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2024-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-01
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2024-07-10
HWA	Impactor	Orthopedic	Class 1	888.4540	2024-07-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HXB	Probe	Orthopedic	Class 1	888.4540	2024-07-01
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2024-07-10
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2024-07-01
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2025-07-29
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2025-07-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-01
EHO	Bar, Preformed	Dental	Class 1	872.3165	2025-07-19
HFI	Coagulator, Culdoscopic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2024-07-10
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
HFI	Coagulator, Culdoscopic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2025-08-11
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2025-07-29
BWA	Unit, Electrosurgical And Coagulation, With Accessories	General, Plastic Surgery	Class 2	878.4400	2025-08-18
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2024-07-10
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-07-01
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2025-08-11
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2024-07-11
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2024-07-11
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-08-13
OJG	Neurological Tray	Neurology	Class 1	882.4525	2025-08-11
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2024-07-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-07-01
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2024-07-02
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2024-07-01
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2024-07-11
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2024-07-01
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-08-16
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-07-01
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2024-07-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-08-20
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2025-08-11
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-11
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2024-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006554912	STERIS Deutschland GmBh	Wurmlingen Baden-Wurttemberg, DE
1526531	STERIS Corporation	CLEVELAND, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1923569. Last updated year: 2026. Please use registration number 1923569 when referencing this establishment in official correspondence.