SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER— 510(k) K972109
Substantially EquivalentGeneral Surgical Innovations
FDA 510(k) clearance K972109 for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER, Substantially Equivalent on 1997-11-14. Applicant: General Surgical Innovations. Device class: 1.
Clearance details
- Applicant
- General Surgical Innovations
- Product code
- Code FZW
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cupertino, CA, US
Recent devices under product code FZW
view allMore clearances from General Surgical Innovations
view all- K983318 — FIXATION SYSTEM
- K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK
- K970201 — GSI CANNULA WITH INTRODUCER
- K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
- K961356 — MAMMARY SIZER
Adverse events under product code FZW
product code FZW- Malfunction
- 3,067
- Total
- 3,067
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.