The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Lariat, Hot/cold Snare.
Device ID | K200745 |
510k Number | K200745 |
Device Name: | Lariat, Hot/Cold Snare |
Classification | Snare, Flexible |
Applicant | United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
Contact | Carroll Martin |
Correspondent | Carroll Martin United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-23 |
Decision Date | 2020-04-21 |