The following data is part of a premarket notification filed by Urohealth Systems, Inc. with the FDA for Pivotal Scissor.
| Device ID | K972510 |
| 510k Number | K972510 |
| Device Name: | PIVOTAL SCISSOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UROHEALTH SYSTEMS, INC. 8850 M-89 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell UROHEALTH SYSTEMS, INC. 8850 M-89 Richland, MI 49083 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-11-13 |
| Summary: | summary |