The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Papillotome.
| Device ID | K962346 |
| 510k Number | K962346 |
| Device Name: | PAPILLOTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Gretchen Younker |
| Correspondent | Gretchen Younker UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-18 |
| Decision Date | 1996-08-08 |
| Summary: | summary |