The following data is part of a premarket notification filed by Microvasive with the FDA for Challenger Hot Biopsy Forceps.
| Device ID | K860366 |
| 510k Number | K860366 |
| Device Name: | CHALLENGER HOT BIOPSY FORCEPS |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-03 |
| Decision Date | 1986-04-07 |