The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Snare Flexible.
| Device ID | K924105 |
| 510k Number | K924105 |
| Device Name: | SNARE FLEXIBLE |
| Classification | Snare, Flexible |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Marlin Younker |
| Correspondent | Marlin Younker UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. 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 | 1992-08-13 |
| Decision Date | 1992-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995182653 | K924105 | 000 |
| 10724995182646 | K924105 | 000 |
| 10724995182608 | K924105 | 000 |
| 10724995182592 | K924105 | 000 |
| 10724995182486 | K924105 | 000 |
| 10724995182479 | K924105 | 000 |