The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Procinch Adjustable Loop Device.
| Device ID | K150416 |
| 510k Number | K150416 |
| Device Name: | ProCinch Adjustable Loop Device |
| Classification | Pin, Fixation, Smooth |
| Applicant | STRYKER ENDOSCOPY 5900 OPTICAL COURT San Jose, CA 95138 |
| Contact | Kelly Kucharczyk |
| Correspondent | Kelly Kucharczyk STRYKER ENDOSCOPY 5900 OPTICAL COURT San Jose, CA 95138 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327137392 | K150416 | 000 |
| 07613327137385 | K150416 | 000 |