The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Kensey Nash Wuik-sert(tm) Endoscopic Surg Grasper.
| Device ID | K926089 |
| 510k Number | K926089 |
| Device Name: | KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KENSEY NASH CORP. 55 EAST UWCHLAN AVE. MARSH CREEK CORP. CENTER Exton, PA 19341 -1247 |
| Contact | Julie C Nash |
| Correspondent | Julie C Nash KENSEY NASH CORP. 55 EAST UWCHLAN AVE. MARSH CREEK CORP. CENTER Exton, PA 19341 -1247 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-02 |
| Decision Date | 1993-07-23 |