The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Procinch Adjustable Loop Device.
| Device ID | K210078 |
| 510k Number | K210078 |
| Device Name: | Stryker ProCinch Adjustable Loop Device |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Contact | Victoria Milich |
| Correspondent | Victoria Milich Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-12 |
| Decision Date | 2021-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327543117 | K210078 | 000 |