The following data is part of a premarket notification filed by Enable Medical Corp. with the FDA for Bipolar Scissors.
| Device ID | K972558 |
| 510k Number | K972558 |
| Device Name: | BIPOLAR SCISSORS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENABLE MEDICAL CORP. 6345 CENTRE PARK DR. West Chester, OH 45069 -3863 |
| Contact | Michael D Hooven |
| Correspondent | Michael D Hooven ENABLE MEDICAL CORP. 6345 CENTRE PARK DR. West Chester, OH 45069 -3863 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-09 |
| Decision Date | 1997-10-07 |
| Summary: | summary |