SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK— 510(k) K973046
Substantially EquivalentGeneral Surgical Innovations
FDA 510(k) clearance K973046 for SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK, Substantially Equivalent on 1998-01-16. Applicant: General Surgical Innovations. Device class: 2.
Clearance details
- Applicant
- General Surgical Innovations
- 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
- Cupertino, CA, US
Recent devices under product code GCJ
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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 General Surgical Innovations
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.