The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Irrigation/aspiration Polypectomy.
| Device ID | K970356 |
| 510k Number | K970356 |
| Device Name: | IRRIGATION/ASPIRATION POLYPECTOMY |
| Classification | Snare, Flexible |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Gretchen R Younker |
| Correspondent | Gretchen R Younker UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-30 |
| Decision Date | 1997-03-25 |
| Summary: | summary |