WEXLER SURGICAL, INC.

FDA Device Registration & Listing · HOUSTON, TX, US · Registration 1646747

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1646747
FEI Number
1000160162
Entity Name
WEXLER SURGICAL, INC.
City/State/Country
HOUSTON, TX, US
Establishment Address
11333 Chimney Rock Rd Suite 110-120, HOUSTON, TX 77035, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
WEXLER SURGICAL, INC. (Owner Number: 9008378)
Owner / Operator Contact Address
11333 CHIMNEY ROCK RD., SUITE # 110-120, Houston, TX 77035, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Clip, iris retractor Burrow SIZER, HEART-VALVE, PROSTHESIS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTZ Caliper Orthopedic Class 1 888.4150 2006-07-21
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2006-07-21
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2006-07-21
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2006-07-21
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2006-08-08
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2006-07-21
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2006-07-21
HTD Forceps General, Plastic Surgery Class 1 878.4800 2006-07-21
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2006-07-21
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2006-08-08
KBT Punch, Tonsil Ear, Nose, Throat Class 1 874.4420 2006-08-08
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2006-07-21
DRC Trocar Cardiovascular Class 2 870.1390 2018-01-26
HPP Headlamp, Operating, Battery-Operated Ophthalmic Class 1 886.4335 2010-01-06
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-08
FQK Binder, Perineal General Hospital Class 1 880.5160 2006-08-08
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2006-08-08
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2006-08-08
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-08
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
EMI File, Bone, Surgical Dental Class 1 872.4565 2006-08-08
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 2016-06-28
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2006-08-08
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2006-07-21
FTX Mirror, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
FKC Clamp, Cannula Gastroenterology, Urology Class 1 876.5540 2006-07-21
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2006-07-21
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2006-07-21
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2006-07-21
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2006-07-21
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2006-08-08
EIG Retractor, All Types Dental Class 1 872.4565 2006-07-21
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
GAD Retractor General, Plastic Surgery Class 1 878.4800 2006-07-21
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2025-02-07
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2006-07-21
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2006-08-08
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2006-08-08
EMD Hemostat, Surgical Dental Class 1 872.4565 2006-07-21
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2006-07-21
EKE Curette, Operative Dental Class 1 872.4565 2006-07-21
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2006-07-21
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2006-08-08
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2006-07-21
MDR Binder, Medical, Therapeutic General Hospital Class 1 880.5160 2006-08-08
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2011-05-23
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
OHW Burr, Corneal, Battery Powered, Rust Ring Removal Ophthalmic Class 1 886.4070 2015-09-04
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
FHI Ring, Laparotomy Gastroenterology, Urology Class 1 876.4730 2006-07-21
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2006-07-21
MWS Stabilizer, Heart Cardiovascular Class 1 870.4500 2006-08-08
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2006-07-21
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2006-07-21
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2006-07-21
HXX Screwdriver Orthopedic Class 1 888.4540 2006-08-08
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2006-08-08
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2006-07-21
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2006-07-21
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2006-07-21
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2015-09-04
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2006-08-08
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2006-08-08
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2006-07-21
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2006-08-08
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2006-07-21
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2006-07-21
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2006-08-08
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2006-07-21
HXD Clamp General, Plastic Surgery Class 1 878.4800 2006-07-21
HBQ Instrument, Clip Removal Neurology Class 1 882.4200 2006-07-21
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2008-12-09
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 2006-08-08
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2006-07-21
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2006-08-08
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2006-07-21
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2006-07-21
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2006-07-21
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2006-07-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2011-05-23
HTF Curette General, Plastic Surgery Class 1 878.4800 2006-07-21
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2006-08-08
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-08-08
NNU Scissors, Wire Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2006-07-21
HXS Twister, Wire Orthopedic Class 1 888.4540 2006-07-21
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2006-07-21
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2006-08-08
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2006-07-21
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2006-08-08
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-07-21

Official Correspondent

Victor Grinshtein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WEXLER SURGICAL, INC.
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
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K871646 Ocular Instruments, Inc. TANNE CORNEAL CUTTING BLOCK 1987-05-18
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0019-2023 Hobbs Medical, Inc. 1
Hobbs Scope Introducer Catalog Number: 4650

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1646747. Last updated year: 2026. Please use registration number 1646747 when referencing this establishment in official correspondence.
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