Data / Medical devices / Pakistan / Quality Concept (pvt) Ltd.

Quality Concept (pvt) Ltd.: FDA-registered device maker in SIALKOT Punjab, Pakistan, 1 510(k) clearance

Name: Quality Concept (pvt) Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Quality Concept (pvt) Ltd. is registered with the FDA (registration 3002090132) in SIALKOT Punjab, Pakistan. It lists 46 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 1, 2005. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002090132
Address: 15-A /01 Small Industrial Estate, SIALKOT Punjab, Pakistan, --
Owner or operator: QUALITY CONCEPT (PVT) LTD. (9051639)
Roles: Manufacturer
First device listed: June 12, 2002
Registered through: 2026
Brand names listed: ARTICULATORS, BLADES, CLAMP, EYELID, OPHTHALMIC, CURETTE, ELEVATOR, FORCEP ENT EAR PUNCH, FORCEPS, GAG, MOUTH and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Articulators	EJP	1	Manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Manufacturer	accessdata.fda.gov
Clamp, Circumcision	HFX	2	Manufacturer	accessdata.fda.gov
Clamp, Eyelid, Ophthalmic	HOD	1	Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer	accessdata.fda.gov
Curette	HTF	1	Manufacturer	accessdata.fda.gov
Curette, Ear	JYG	1	Manufacturer	accessdata.fda.gov
Cutter, Surgical	FZT	1	Manufacturer	accessdata.fda.gov
Depressor, Metal Tongue, Surgical	KBL	1	Manufacturer	accessdata.fda.gov
Dilator, Tracheal	KCG	1	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Forceps, Ent	KAE	1	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Fork, Tuning	GWX	1	Manufacturer	accessdata.fda.gov
Gag, Mouth	KBN	1	Manufacturer	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	Manufacturer	accessdata.fda.gov
Hammer, Surgical	FZY	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Hemostat	HRQ	1	Manufacturer	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Knife, Surgical	EMF	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Remover, Crown	EIS	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Manufacturer	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Manufacturer	accessdata.fda.gov
Sound, Uterine	HHM	1	Manufacturer	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Manufacturer	accessdata.fda.gov
Syringe, Ent	KCP	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trephine, Manual, Ophthalmic	HRH	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 1, 2005	K043533	SURGICAL DESIGN CIRCUMCISION CLAMP	HFX	Substantially Equivalent	Surgical Design, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 1, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.