The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Truclear Ultra Mini Tissue Removal Device.
| Device ID | K161763 |
| 510k Number | K161763 |
| Device Name: | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device |
| 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 | 2016-06-27 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556584859 | K161763 | 000 |
| 90884521744093 | K161763 | 000 |