The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Spacemaker Surgical Balloon Dissector, Spacemaker Ii Surgical Balloon Dissector, Saphtrak.
| Device ID | K973046 |
| 510k Number | K973046 |
| Device Name: | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. Cupertino, CA 95014 |
| Contact | Cathleen Mantor |
| Correspondent | Cathleen Mantor GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. Cupertino, CA 95014 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-15 |
| Decision Date | 1998-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521051529 | K973046 | 000 |
| 10884521068056 | K973046 | 000 |
| 10884521068049 | K973046 | 000 |