The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Truclear Morcellation System And Truclear Morcellators.
| Device ID | K132015 |
| 510k Number | K132015 |
| Device Name: | TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Bradley Heil |
| Correspondent | Bradley Heil SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-12-13 |
| Summary: | summary |