The following data is part of a premarket notification filed by United States Endoscopy Group, Inc with the FDA for Isnare System-lariat.
| Device ID | K152035 |
| 510k Number | K152035 |
| Device Name: | ISnare System-Lariat |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2015-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012748 | K152035 | 000 |
| 10724995180789 | K152035 | 000 |