Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015351976

FEI Number

3015351976

Entity Name

TEKMODE

City/State/Country

Akbarabad, Sialkot Punjab, PK

Establishment Address

Pasrur Bypass Road, Near Haider Flour Mills, Akbarabad, Sialkot Punjab 0000, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TEKMODE (Owner Number: 10079432)

Owner / Operator Contact Address

Pasrur Bypass Road, Near Haider Flour Mills, Akbarabad, Sialkot, PK-NOTA 0000, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HOOK, SURGICAL, GENERAL & PLASTIC SURGERY DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY CURETTE, SURGICAL, GENERAL USE Scissors, General, Surgical GAG, MOUTH SPECULUM, ENT CUTTER, SURGICAL SOUND, UTERINE OSTEOTOME TUBE, TONSIL SUCTION Headlamp, operating, battery-operated MARKER, SKIN Surgical Tray Laryngoscope ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY FORCEPS, ENT SPECULUM, VAGINAL, METAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-01-02
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-05-21
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-02
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-06-29
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2025-05-29
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2025-05-29
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-02-02
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2026-01-02
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2026-05-21
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2026-01-02
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2026-01-10
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2026-05-21
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-08-04
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2020-12-06
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-05-21
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2026-01-10
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2023-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

TEKMODE

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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
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-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Similar Registrations

Registration Number	Establishment Name	Location
3006128100	Nemcomed FW LLC	FORT WAYNE, IN, US
3007840839	HOLGER BUMUELLER LLC	Rutherfordton, NC, US
1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
9681161	REBSTOCK INSTRUMENTS GMBH	DUERBHEIM Baden-Wurttemberg, DE
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015351976. Last updated year: 2026. Please use registration number 3015351976 when referencing this establishment in official correspondence.