The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Dsnare, Model 00711087.
| Device ID | K051637 |
| 510k Number | K051637 |
| Device Name: | DSNARE, MODEL 00711087 |
| Classification | Instrument, Biopsy, Suction |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Gretchen Y Cohen |
| Correspondent | Gretchen Y Cohen UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-10-31 |