The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Instinct Endoscopic Hemoclip.
| Device ID | K132809 |
| 510k Number | K132809 |
| Device Name: | INSTINCT ENDOSCOPIC HEMOCLIP |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 |
| Contact | Scottie Fariole |
| Correspondent | Scottie Fariole WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2013-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002246539 | K132809 | 000 |
| 00827002183445 | K132809 | 000 |
| 00827002183438 | K132809 | 000 |