FDA Registration
Active
🇺🇸 United States
WEXLER SURGICAL, INC.
Reg #: 1646747
·
FEI: 1000160162
·
Expires 2026
Products
132
Proprietary Names
6
Establishment Types
2
Classifications
132
Registration Details
- Registration Name
- WEXLER SURGICAL, INC.
- Registration Number
- 1646747
- FEI Number
- 1000160162
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11333 Chimney Rock Rd Suite 110-120
- City
- HOUSTON
- State
- TX
- ZIP
- 77035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110148
Owner / Operator
- Firm Name
- WEXLER SURGICAL, INC.
- Operator Number
- 9008378
- Address
- 11333 CHIMNEY ROCK RD., SUITE # 110-120
- City
- Houston
- State
- TX
- Postal Code
- 77035
- Country
- US
- Correspondent
- Victor - Grinshtein
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Caliper | KTZ | Class 1 | Orthopedic | No | 2006-07-21 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2006-07-21 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2006-07-21 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2006-08-08 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2006-07-21 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2006-07-21 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2006-07-21 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Punch, Tonsil | KBT | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2006-07-21 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2018-01-26 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2010-01-06 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Binder, Perineal | FQK | Class 1 | General Hospital | No | 2006-08-08 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2006-08-08 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2006-07-21 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2006-08-08 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 2016-06-28 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2006-07-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2006-08-08 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Mirror, General & Plastic Surgery | FTX | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Clamp, Cannula | FKC | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2006-07-21 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2006-07-21 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2025-02-07 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2006-07-21 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2006-07-21 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Curette, Operative | EKE | Class 1 | Dental | No | 2006-07-21 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2006-07-21 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2006-07-21 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2006-08-08 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2011-05-23 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2006-07-21 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2015-09-04 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2006-07-21 |
| Ring, Laparotomy | FHI | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2006-07-21 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2006-08-08 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2006-07-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2006-08-08 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2006-07-21 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2006-07-21 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2006-07-21 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2015-09-04 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2006-07-21 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2006-07-21 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Instrument, Clip Removal | HBQ | Class 1 | Neurology | No | 2006-07-21 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2008-12-09 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2006-07-21 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2006-08-08 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2006-07-21 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2011-05-23 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2006-07-21 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2006-07-21 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2006-07-21 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 2006-08-08 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2006-07-21 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2006-08-08 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2006-07-21 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2006-07-21 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2006-07-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2006-07-21 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2006-07-21 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2008-12-09 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2006-07-21 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2006-07-21 |
| Instrument, Measuring, Corneal Radius | HJB | Class 1 | Ophthalmic | No | 2006-07-21 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2015-09-04 |
| Binder, Elastic | KMO | Class 1 | General Hospital | No | 2006-07-21 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2006-08-08 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2006-08-08 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2006-08-08 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2006-07-21 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2006-08-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2006-07-21 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2006-07-21 |
Proprietary Names
Clip, iris retractor
Burrow
SIZER, HEART-VALVE, PROSTHESIS
Cannula, ophthalmic, posterior capsular polishing, polyvinyl acetal
Instrument, measuring, corneal radius
TRAY, SURGICAL, INSTRUMENT
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility