K973046 is an FDA 510(k) clearance for the SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by General Surgical Innovations (Cupertino, US). The FDA issued a Cleared decision on January 16, 1998, 154 days after receiving the submission on August 15, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K973046 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 15, 1997 |
| Decision Date | January 16, 1998 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCJ — Laparoscope, General & Plastic Surgery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |