K972109 is an FDA 510(k) clearance for the SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER, a Expander, Surgical, Skin Graft (Class I — General Controls, product code FZW), submitted by General Surgical Innovations (Cupertino, US). The FDA issued a Cleared decision on November 14, 1997, 162 days after receiving the submission on June 5, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K972109 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 1997 |
| Decision Date | November 14, 1997 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZW — Expander, Surgical, Skin Graft |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |