The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Weck Trocar.
| Device ID | K915378 |
| 510k Number | K915378 |
| Device Name: | WECK TROCAR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Glenn Mattei |
| Correspondent | Glenn Mattei EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-06-29 |