The following data is part of a premarket notification filed by Endovations with the FDA for Polypectomy Snare.
| Device ID | K862060 |
| 510k Number | K862060 |
| Device Name: | POLYPECTOMY SNARE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Karen S Butt |
| Correspondent | Karen S Butt ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-30 |
| Decision Date | 1986-06-27 |