Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011499367

FEI Number

3011499367

Entity Name

HAZEL ENTERPRISES

City/State/Country

Sialkot Punjab, PK

Establishment Address

Near F.S. CANDINO, Defence Road, Sialkot Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hazel Enterprises (Owner Number: 10047908)

Owner / Operator Contact Address

Near F.S. CANDINO, Defence Road, 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

HANDLE, SCALPEL CURETTE TUBE, TONSIL SUCTION RONGEUR CUTTER, SURGICAL LARYNGOSCOPE, RIGID CIRCUMCISION,CLAMP Specula, ophthalmic SCISSORS, GENERAL, SURGICAL SAW Trephine Blade, Punch,Ophthalmic Dilator, catheter SPECULUM, RECTAL INSTRUMENT, LIGATURE PASSING AND KNOT TYING ( HEMORRHOIDAL Clamp ) KNIFE, SURGICAL PROBE HOLDER, NEEDLE, GASTROENTEROLOGIC FORCEPS, GENERAL & PLASTIC SURGERY INSTRUMENT, FILLING, PLASTIC, DENTAL HOOK, SURGICAL, GENERAL & PLASTIC SURGERY EYE INSTRUMENT CLAMP (SPECULUM) Ophthalmoscope, POCKET AND Standard Ophthalmoscope, powered ENT & DENTAL NASAL SPECULUM ENT Bone Saws; Wire Saws,satterlee bone saw CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY AMALGAM CARRIER, DENTAL; Amalgam Carrier, Regular/Jumbo; Amalgam Carrier/Amalgam Well Non Slip PROBE, PERIODONTIC REMOVER, CROWN TRAY, SURGICAL, INSTRUMENT SOUND, UTERINE SCISSORS, ORTHOPEDIC, SURGICAL CHISEL, BONE, SURGICAL HEMORRHOID LIGATOR FORCEPS TRAY, IMPRESSION, PREFORMED FORCEPS COMBINATION FORCEPS SPECULUM, VAGINAL, METAL Fork,Tunning PINWHEEL DENTAL CLAMP ( Tofflimire ) ARTICULATORS EXPLORER, OPERATIVE OTOSCOPE GAG, MOUTH HANDLE, INSTRUMENT, DENTAL SCALER, PERIODONTIC ELEVATOR, SURGICAL, DENTAL BURNISHER, OPERATIVE PROBE AND DIRECTOR, GASTRO-UROLOGY MIRROR, MOUTH EAR SPECULAS SPECULA ACCESSORIES RETRACTORS PLIERS, SURGICAL diagnostic pen light

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-11-14
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2025-05-12
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2025-05-08
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-05-12
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-02-17
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2019-08-28
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2025-07-21
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-05-08
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-11-13
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2025-05-12
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-05-09
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-12-07
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2025-05-09
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2025-05-09
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-05-12
HXB	Probe	Orthopedic	Class 1	888.4540	2025-05-12
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2014-11-14
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-04-07
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2025-05-12
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-05-12
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-05-09
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2025-05-09
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2025-05-09
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2025-05-09
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-05-08
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2025-05-09
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2015-02-17
EIS	Remover, Crown	Dental	Class 1	872.4565	2025-05-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-03-02
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2025-05-08
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2025-05-12
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2025-05-12
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2025-05-09
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2025-05-12
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-11-13
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2014-11-14
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2025-05-08
GWY	Pinwheel	Neurology	Class 1	882.1750	2025-05-09
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2025-05-09
EJP	Articulators	Dental	Class 1	872.3150	2025-05-12
EKB	Explorer, Operative	Dental	Class 1	872.4565	2015-02-17
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2019-08-28
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2015-03-27
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2025-05-09
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2015-02-17
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2025-05-09
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2025-05-09
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2025-05-09
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2015-03-02
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	2015-04-29
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-01-17
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-05-09
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2025-05-09

Official Correspondent

Muhammad Shabbir

US Agent Details

Mohammad Bashir Business: Surgical Design Inc Email: surgicaldesign@erols.com Phone: (703) 5410196

Related Public Records

Same Entity

Hazel Enterprises

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
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
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3007389672	FRANKO SHEHZAD SURGICO PVT LTD.	Sialkot Punjab, PK
3022748632	TAURUS Medizintechnik GmbH	Fridingen an der Donau Baden-Wurttemberg, DE
3012267976	SURGIPROS LLC	Palmetto, FL, US
8040179	BASHIR JAMIL & BROTHERS (PVT.), LTD.	Sialkot Punjab, PK
2087382	DG Instruments	GRANTS PASS, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011499367. Last updated year: 2026. Please use registration number 3011499367 when referencing this establishment in official correspondence.