The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Truclear Operative Hysteroscope 5c And Sheath 5c.
| Device ID | K152143 |
| 510k Number | K152143 |
| Device Name: | TRUCLEAR Operative Hysteroscope 5C And Sheath 5C |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SMITH & NEPHEW, INC. 150 Minuteman Road Andover, MA 01810 |
| Contact | Bradley Heil |
| Correspondent | Bradley Heil SMITH & NEPHEW, INC. 150 Minuteman Road Andover, MA 01810 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556583685 | K152143 | 000 |
| 00885556583654 | K152143 | 000 |
| 10884521746695 | K152143 | 000 |
| 10884521746688 | K152143 | 000 |
| 10884521746756 | K152143 | 000 |