Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005974802

FEI Number

3005974802

Entity Name

GYNAMED INSTRUMENTS

City/State/Country

Sialkot Punjab, PK

Establishment Address

Street Prof Abdullah, Ghous Pura, Kacha Shahab Pura, Sialkot Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gynamed Instruments (Owner Number: 10062687)

Owner / Operator Contact Address

Street Prof Abdullah, Ghous Pura, Kacha Shahab Pura, Sialkot, PK-PB 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARTICULATED, Self retaining multi purpose Retractors & Stays/Hooks Pin Cutter. Side cutting. Capacity 6.3mm. Overall length 22-3/8in (56.8cm) A08/60 - Suture Guide Cone Dia8.25x60mm, Holes 02 A08/100 - Suture Guide Cone Dia8.25x100mm, Holes 02 A13/100 - Suture Guide Cone Dia13.50x100mm, Holes 02 A15/60 - Suture Guide Cone Dia15.75x60mm, Holes 02 A11/100 - Suture Guide Cone Dia11.25x100mm, Holes 02 A13/60 - Suture Guide Cone Dia13.50x60mm, Holes 02 B15/60 - Suture Guide Cone Dia15.75x60mm, Holes 04 A15/100 - Suture Guide Cone Dia15.75x100mm, Holes 02 B13/60 - Suture Guide Cone Dia13.50x60mm, Holes 04 B08/60 - Suture Guide Cone Dia8.25x60mm, Holes 04 B11/60 - Suture Guide Cone Dia11.25x60mm, Holes 04 A11/60 - Suture Guide Cone Dia11.25x60mm, Holes 02 B13/100 - Suture Guide Cone Dia13.50x100mm, Holes 04 B15/100 - Suture Guide Cone Dia15.75x100mm, Holes 04 B08/100 - Suture Guide Cone Dia8.25x100mm, Holes 04 B11/100 - Suture Guide Cone Dia11.25x100mm, Holes 04 Allis Tissue Forceps, 6"; Allis Tissue Forceps, 7"; Allis Tissue Forceps, 8"; S Shape Autraumatic Forceps 9½" Allis Tissue Forceps, 8" S Shape Autraumatic Forceps 9½" Allis Tissue Forceps, 7" Allis Tissue Forceps, 6" Garrett Dilators GYNAMED CORPUS Cavernosia, Double Ended, Sharp Tip, 27cm Long Available in 6 Sizes GYNAMED CORPUS Cavernosia, Double Ended, Blunt Tip, 20cm Long Available in 6 Sizes PENILE Surgical Instruments Accessories Set GYNAMED CORPUS Cavernosia, Double Angle Dilators, Length 30.5cm, Available in 7 Sizes and Sets GYNAMED CORPUS Cavernosia Dilator, Measure with Handle, Blunt Tip, 22cm GYNAMED CORPUS Cavernosia Dilator, Measure with Handle, Sharp Tip, 22cm GYNAMED CORPUS Cavernosia, Shaving Double Blades, Length 23.5cm, Available in 8 Sizes and Sets Tea/Coffee Spoon, 135mm Big Tea Spoon, 160mm Desert Spoon, 185mm Demittase Spoon, 110mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2020-08-10
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2020-06-28
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2020-03-02
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2020-03-02
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-03-02
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2020-08-10
JZE	Spoon, Ear	Ear, Nose, Throat	Class 1	874.4420	2020-03-02

Official Correspondent

Waqas Ahmed

US Agent Details

ALI UMAIR Email: au.umair15@gmail.com Phone: (804) 9443173

Related Public Records

Same Entity

Gynamed Instruments

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005974802. Last updated year: 2026. Please use registration number 3005974802 when referencing this establishment in official correspondence.