FDA Registration
Active
🇵🇰 Pakistan
EMPIRE SURGICAL INSTRUMENTS COMPANY
Reg #: 3013358456
·
FEI: 3013358456
·
Expires 2026
Products
73
Proprietary Names
1
Establishment Types
3
Classifications
73
Registration Details
- Registration Name
- EMPIRE SURGICAL INSTRUMENTS COMPANY
- Registration Number
- 3013358456
- FEI Number
- 3013358456
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 786 Muradia Road, Model Town
- City
- Sialkot Punjab
- Country
- PK
Regulatory Submissions
- 510(k) Number
- K040052
Owner / Operator
- Firm Name
- Empire Surgical Instruments Company
- Operator Number
- 10054691
- Address
- 786 Muradia Road, Model Town
- City
- Sialkot
- State
- Punjab
- Postal Code
- 51311
- Country
- PK
- Correspondent
- Shoaib Zafar
US Agent
- Business Name
- FINE SURGICAL INSTRUMENTS INC.
- Contact Name
- Aizaz Akram
- Address
- 50-54 POLK Ave, Hempstead, New York
- City
- Hempstead
- State
- NY
- ZIP
- 11550
- Country
- US
- [email protected]
- Phone
- 516 2927400 ext. 12
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2017-12-19 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2017-11-16 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2017-10-31 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2017-07-17 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2017-12-19 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2017-10-30 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2017-10-19 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2017-10-31 |
| Urinal | FNP | Class 1 | General Hospital | No | 2017-05-05 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2017-05-05 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2017-12-19 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2017-10-30 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2017-10-19 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2017-10-30 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2017-10-19 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2017-10-31 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2017-11-16 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2017-09-15 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2017-11-13 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2017-10-31 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2017-10-31 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2017-10-31 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2017-10-31 |
| Pelvimeter, External | HER | Class 1 | Obstetrics/Gynecology | No | 2017-05-05 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2017-12-05 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2017-11-16 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2017-11-24 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2017-05-05 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2017-10-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2017-05-25 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2017-10-31 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2017-10-19 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2017-05-05 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2017-10-31 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2017-10-19 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2017-10-30 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2017-10-31 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2017-10-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2017-12-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2017-10-30 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2017-05-05 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2017-10-30 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2017-10-30 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2017-12-19 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2017-10-31 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2017-05-05 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2017-05-05 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2017-10-19 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2017-06-15 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-12-05 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2017-10-19 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2017-10-19 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2017-10-30 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2017-11-16 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2017-10-04 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2017-11-16 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2017-05-05 |
| Scissors, Wire Cutting, Ent, Sterile | JYA | Class 1 | Ear, Nose, Throat | No | 2017-11-16 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2017-04-15 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2017-10-31 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2017-10-19 |
| Percussor | GWZ | Class 1 | Neurology | No | 2017-10-19 |
Proprietary Names
EMPSURG
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Remanufacture Medical Device