The following data is part of a premarket notification filed by Weck Endoscopy with the FDA for Endoscopic Scissors (disposable/reusable Shafts).
| Device ID | K926203 |
| 510k Number | K926203 |
| Device Name: | ENDOSCOPIC SCISSORS (DISPOSABLE/REUSABLE SHAFTS) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WECK ENDOSCOPY P.O. BOX 12600 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Joseph A Mertis |
| Correspondent | Joseph A Mertis WECK ENDOSCOPY P.O. BOX 12600 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-09 |
| Decision Date | 1993-10-15 |