Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004784004

FEI Number

3004784004

Entity Name

SOBYTEK INSTRUMENTS CO.

City/State/Country

SIALKOT Punjab, PK

Establishment Address

4KM Sambrial Road Daska, SIALKOT Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SOBYTEK INSTRUMENTS CO. (Owner Number: 9076464)

Owner / Operator Contact Address

SOBYTEK INSTRUMENTS CO., 4KM Sambrial Road Daska 51310, SIALKOT, PUNJAB, PK-NOTA 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wire Cutter Orthopedic Screws ENT Knife dental mirror ACESSORIES RETRACTORS TRAYS scissors SYRINGE HOOKS HEMORRHOID LIGATOR FORCEPS mirror handle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2005-08-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-05-05
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2017-05-05
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2017-06-19
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2005-08-15
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2005-08-15
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2005-08-15
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2005-08-15
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-04-02
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2017-05-05
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2013-04-02

Official Correspondent

KHALIQ MUGHAL

US Agent Details

Zulfiqar A Bajwa Email: zulfiqar_bj@yahoo.com Phone: (516) 7101023

Related Public Records

Same Entity

SOBYTEK INSTRUMENTS CO.

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
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3012995405	SURGIX MEDICAL LLC	Spring, TX, US
3002862271	Wenzler Medizintechnik GmbH	Frittlingen Baden-Wurttemberg, DE
8010733	PRO-MED INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3015895045	Sklar Corporation - Warehouse	Salisbury, MD, US
2132732	TECOMET, INC.	KENOSHA, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004784004. Last updated year: 2026. Please use registration number 3004784004 when referencing this establishment in official correspondence.