The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Tissue Morcellator.
| Device ID | K910939 |
| 510k Number | K910939 |
| Device Name: | COOK TISSUE MORCELLATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-06-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COOK TISSUE MORCELLATOR 74268461 1818429 Dead/Cancelled |
Cook Incorporated 1992-04-23 |