Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012995405

FEI Number

3012995405

Entity Name

SURGIX MEDICAL LLC

City/State/Country

Spring, TX, US

Establishment Address

22317 GOSLING RD, Spring, TX 77389, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Surgix Medical, L.L.C. (Owner Number: 10052923)

Owner / Operator Contact Address

22317 Gosling Rd, Spring, TX 77389, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Bedding Wire Cutter Hemostatic Forceps GEN2 Rasp Surgical Instrument Non-powered Ophthalmic Caliper Surgical Guide Instrument Spatula Ear Scissors Dissector Microsurgical Instrument Forceps Lachrymal Dilator GEN2 VAGINAL RETRACTOR Loop, Wire Currette Tonsil Needle Ligature Passing and Knot Tying Instrument Amputation Knife Nasal Chisel Surgical Knife Gouge Bone Skid Nasal Scissors Gen2 Clampbox Gen2 Single Clamp Gen2 Clamp Kay Aortic Clamp Gen2 Approximator Clamp Bowman Probe Instrument Stringer W/Bar 6" X 2.5" Ear Measuring Rod GEN2 Trabeculotomy Probe Scissors, Surgical Self-Retaining Retractor ENT Punch GEN2 Ventricular Cannula Forceps, ENT Orbital Depressor Nipper, Malleus Bone Impactor Tongue Depressor Reamer Retractor Segmented Oval Ring GEN2 Female Catheter Lachrymal Probe GEN 2 Orthopedic Instrument GEN2 Tuning Fork GEN2 Uterine Curette Ear Knife Rongeur GRAVES VAGINAL SPECULUM MEDIUM BW35mm BL 106MM OL 5 1/8" Cohen Acorn Cannula Intrauterine Probe Spring-mount Forcep,Small and Large Cones,Diameter 3.5mmOL369mm(14 1/2") Cohen Acorn Small Cone, Tube 3.24mm, TL 31mm OL 60mm(2 3/8") Non-sterile ENT Wire Crimper Multihole Suction Tube Bender Chisel Nasal Knife Needle Holder Rasp Surgical Instrument Tray Middle-ear Chisel Ophthalmic Cannula Retractor GEN2 UTERINE SOUND Forceps Bone Chisel ENT Manual Surgical Instrument Blade, Saw, General & Plastic Surgery GEN2 Uterine Grasping Forcep Scapel Handle Specula GEN2 SPECULA ENT Knife Probe and Director Suction Tube Manual Surgical Instrument GARRETT VASCULAR DILATOR VASCULAR DILATOR Iris Scissors Ligature Carrier GEN2 GYN FORCEPS Surgical Table Disposable Cover Kit GEN2 BIO FORCEP Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-06-09
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2022-03-21
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2022-03-17
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-01-03
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2022-03-21
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-03-21
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-03-21
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-21
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-17
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2022-03-21
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-17
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2022-03-21
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2023-01-05
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2025-06-12
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-03-17
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2022-03-21
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2025-02-06
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2022-03-21
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-03-21
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-21
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2022-03-21
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2022-09-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-03-21
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2024-09-16
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-03-17
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2022-03-21
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HCD	Cannula, Ventricular	Neurology	Class 1	882.4060	2026-04-09
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2022-03-21
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HWA	Impactor	Orthopedic	Class 1	888.4540	2022-03-21
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-03-21
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2022-04-18
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2023-08-31
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2025-06-12
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2024-01-03
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2024-01-03
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2023-01-05
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2022-04-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-04-26
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2022-03-21
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-04-18
HXW	Bender	Orthopedic	Class 1	888.4540	2022-03-21
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2022-03-21
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2022-03-17
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-03-21
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-03-21
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2022-02-15
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-03-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2022-03-17
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2023-01-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-01-08
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2022-03-21
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2022-03-21
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2023-08-31
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-03-21
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2022-03-21
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2023-01-05
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2022-03-21
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2022-03-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-03-21
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2022-04-18
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-03-21
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2022-03-17
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2023-01-05
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-06-05
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2023-01-05
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2022-03-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Surgix Medical, L.L.C.

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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012995405. Last updated year: 2026. Please use registration number 3012995405 when referencing this establishment in official correspondence.