The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Videoarthroscope.
| Device ID | K043395 |
| 510k Number | K043395 |
| Device Name: | SMITH & NEPHEW VIDEOARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Kathleen Burns |
| Correspondent | Kathleen Burns SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556611081 | K043395 | 000 |
| 00885554018783 | K043395 | 000 |
| 00885554023350 | K043395 | 000 |
| 00885554023367 | K043395 | 000 |
| 00885554024159 | K043395 | 000 |
| 00885554024166 | K043395 | 000 |
| 00885554024173 | K043395 | 000 |
| 00885554024180 | K043395 | 000 |
| 00885554024197 | K043395 | 000 |
| 00885554024203 | K043395 | 000 |
| 00885554024210 | K043395 | 000 |
| 00885554024227 | K043395 | 000 |
| 00885554024234 | K043395 | 000 |
| 00885554026085 | K043395 | 000 |
| 00885554026245 | K043395 | 000 |
| 00885554026252 | K043395 | 000 |
| 00885554026269 | K043395 | 000 |
| 00885554026276 | K043395 | 000 |
| 00885554018776 | K043395 | 000 |