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GPC Medical Limited: FDA-registered device maker in Ghaziabad Uttar Pradesh, India, 6 510(k) clearances

Name: GPC Medical Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GPC Medical Limited is registered with the FDA (registration 3006513362) in Ghaziabad Uttar Pradesh, India. It lists 31 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 10, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006513362
Address: Plot C-3, Sec B-1, UPSIDC Trans Delhi Signature City, Loni, Ghaziabad Uttar Pradesh, India, 201102
Owner or operator: GPC MEDICAL LIMITED (10025272)
Roles: Manufacturer
First device listed: March 29, 2008
Registered through: 2026
Brand names listed: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE, BAG, RESERVOIR, REBREATHING BAG-GPC, BED, AC-POWERED ADJUSTABLE HOSPITA,FOWLER BED WITH ABS PANELS & COLLAPSIBLE RAILINGSL-GPC, BED, HYDRAULIC, ADJUSTABLE HOSPITAL-GPC, BED, PEDIATRIC OPEN HOSPITAL-GPC, BIT, DRILL-GPC, Blade Sizes 000, 00,0,1,2,3,4,5 Reusable,, Blade Sizes 000, 00,0,1,2,3,4,5-Reusable, and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Manufacturer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Manufacturer	accessdata.fda.gov
Bed, Ac-Powered Adjustable Hospital	FNL	2	Manufacturer	accessdata.fda.gov
Bed, Hydraulic, Adjustable Hospital	FNK	1	Manufacturer	accessdata.fda.gov
Bed, Manual	FNJ	1	Manufacturer	accessdata.fda.gov
Bed, Pediatric Open Hospital	FMS	2	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Manufacturer	accessdata.fda.gov
Cap, Bone	JDT	1	Manufacturer	accessdata.fda.gov
Countersink	HWW	1	Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Manufacturer	accessdata.fda.gov
Device, Rebreathing	BYW	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov
Nail, Fixation, Bone	JDS	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Passer	HWQ	1	Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Manufacturer	accessdata.fda.gov
Stretcher, Hand-Carried	FPP	1	Manufacturer	accessdata.fda.gov
Stretcher, Wheeled	FPO	2	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Twister, Wire	HXS	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
February 10, 2022	K203811	GPC Intraheal Intramedullary Nailing System	HSB	Substantially Equivalent	Gpc Medical Limited	accessdata.fda.gov
January 7, 2022	K210198	GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive	HRS	Substantially Equivalent	Gpc Medical Limited	accessdata.fda.gov
March 31, 2017	K163096	GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System	NKB	Substantially Equivalent	Gpc Medical Limited	accessdata.fda.gov
May 17, 2016	K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	HRS	Substantially Equivalent	Gpc Medical, Ltd.	accessdata.fda.gov
September 30, 2015	K143245	GPC Intramedullary Nailing Systems	HSB	Substantially Equivalent	Gpc Medical Limited	accessdata.fda.gov
March 29, 2010	K092493	GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM	HRS	Substantially Equivalent	Gpc Medical, Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 10, 2022. 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.