Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010687973

FEI Number

3010687973

Entity Name

FETZER SURGICAL, LLC

City/State/Country

Scottsdale, AZ, US

Establishment Address

9217 E. Verde Grove Vw., Scottsdale, AZ 85255, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Fetzer Surgical, LLC (Owner Number: 10046280)

Owner / Operator Contact Address

9217 E VERDE GROVE VW., Scottsdale, AZ 85255, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cannula, Subprapubic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2018-11-28
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-11-29
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-02-28
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2018-11-28
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2019-10-15
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2018-11-28
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-11-29
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2018-11-29
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-03-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-11-29
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-06-18
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-11-28
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2021-02-22
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2018-11-28
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2019-10-15
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2018-11-28
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-02-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-10-15
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2018-11-29
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2014-02-28
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-28
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2014-02-28
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2021-02-22
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2018-11-29
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2018-11-28
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-02-28
HXB	Probe	Orthopedic	Class 1	888.4540	2018-11-29
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2018-11-28
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-11-28
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2014-02-28
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2019-10-15
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2014-02-27
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2018-11-28
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2019-10-15
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2018-11-29
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2022-03-04
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2019-10-15
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2018-11-28
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2021-06-24
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-02-28
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2018-11-29
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2014-02-28
KAJ	Mobilizer, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-11-29
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2018-11-28
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2019-10-15
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2018-11-28
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-02-28
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-02-28
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-11-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-08
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2018-11-29
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2021-06-24
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-02-28
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-11-29
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-11-28
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2014-02-28
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-02-22
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2014-02-28
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-02-28
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2018-11-29
HXG	Tamp	Orthopedic	Class 1	888.4540	2014-02-28
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-02-28
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2021-06-25
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2018-11-28
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2018-11-29
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2019-10-15
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-05-16
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-02-28
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-02-28
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2014-02-28
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2018-11-28
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2018-11-28
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2018-11-28
HWA	Impactor	Orthopedic	Class 1	888.4540	2018-11-29
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2018-11-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2014-02-27
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2018-11-28
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2018-11-29
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-28
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2018-11-29
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-02-28
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-10-15
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-02-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-11-29
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2021-06-24
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2018-11-28
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2023-12-08
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2014-02-28
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-11-28
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2018-11-28
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2014-02-27
HTX	Rongeur	Orthopedic	Class 1	888.4540	2014-02-28

Official Correspondent

Chad Fetzer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fetzer Surgical, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K810894	American Edwards Laboratories	FOGARTY FLEXIBLE CALIBRATOR	1981-05-15
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
9613926	Gesco Healthcare Private Limited	CHENNAI, Tamil Nadu, IN
8010732	Kohler Medizintechnik GmbH	STOCKACH Baden-Wurttemberg, DE
3008711893	B.Braun Medical (Suzhou) Co,.Ltd	Suzhou Jiangsu, CN
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
3016965929	COMFORT SURGICAL INSTRUMENTS	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010687973. Last updated year: 2026. Please use registration number 3010687973 when referencing this establishment in official correspondence.