GPC Medical Limited
Ghaziabad Uttar Pradesh, IN
GPC MEDICAL LIMITED appears in FDA device records in Ghaziabad Uttar Pradesh, IN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for GPC Medical Limited between 2010 and 2022. The busiest year on record is 2022, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203811 | GPC Intraheal Intramedullary Nailing System | HSB | Substantially Equivalent | |
| 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 | |
| K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System | NKB | Substantially Equivalent | |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | HRS | Substantially Equivalent | |
| K143245 | GPC Intramedullary Nailing Systems | HSB | Substantially Equivalent | |
| K092493 | GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006513362 | 3006513362 | GPC MEDICAL LIMITED | Plot C-3, Sec B-1, UPSIDC, Ghaziabad Uttar Pradesh 201102 IN | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- BTCBag, Reservoir
- FNLBed, Ac-Powered Adjustable Hospital
- FNKBed, Hydraulic, Adjustable Hospital
- FNJBed, Manual
- FMSBed, Pediatric Open Hospital
- HTWBit, Drill
- KTZCaliper
- JDTCap, Bone
- HWWCountersink
- HXZCutter, Wire
- BYWDevice, Rebreathing
- HTJGauge, Depth
- CALLaryngoscope, Non-Rigid
- CCWLaryngoscope, Rigid
- JDSNail, Fixation, Bone
- LXHOrthopedic Manual Surgical Instrument
- HWQPasser
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- HTOReamer
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- LDEStethoscope, Manual
- FPPStretcher, Hand-Carried
- FPOStretcher, Wheeled
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
- HXSTwister, Wire
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain