GS-1000 GRASPING FORCEP, 5MM, INSULATED— 510(k) K900947
Substantially EquivalentSolos Endoscopy, Inc.
FDA 510(k) clearance K900947 for GS-1000 GRASPING FORCEP, 5MM, INSULATED, Substantially Equivalent on 1990-04-18. Applicant: Solos Endoscopy, Inc.. Device class: 2.
Clearance details
- Applicant
- Solos Endoscopy, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
Recent devices under product code GEI
view allMore clearances from Solos Endoscopy, Inc.
view all- K983538 — MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
- K910671 — MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
- K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
- K900949 — GS-1100 MICRO DISSECTING FORCEP, 5MM, INSULATED
- K900950 — GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.