FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM— 510(k) K100442
Substantially EquivalentSurgical Innovations Group Plc
FDA 510(k) clearance K100442 for FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM, Substantially Equivalent on 2010-09-07. Applicant: Surgical Innovations Group Plc. Device class: 2.
Clearance details
- Applicant
- Surgical Innovations Group Plc
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leeds West Yorkshire, GB
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- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Surgical Innovations Group Plc
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.