The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Various Arthroscopes, Endoscopic Blades, Manual Instruments.
| Device ID | K971253 |
| 510k Number | K971253 |
| Device Name: | VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Elizabeth A Ryan |
| Correspondent | Elizabeth A Ryan SMITH & NEPHEW, INC. 160 DASCOMB 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 | 1997-04-03 |
| Decision Date | 1997-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556606650 | K971253 | 000 |
| 00885556606124 | K971253 | 000 |
| 00885556561461 | K971253 | 000 |
| 00885556561454 | K971253 | 000 |
| 00885556561225 | K971253 | 000 |
| 00885556561218 | K971253 | 000 |
| 00885554014778 | K971253 | 000 |
| 00885554005486 | K971253 | 000 |
| 00885554003109 | K971253 | 000 |
| 03596010122322 | K971253 | 000 |
| 03596010122308 | K971253 | 000 |
| 00885556606131 | K971253 | 000 |
| 00885556606247 | K971253 | 000 |
| 00885556606254 | K971253 | 000 |
| 00885556606643 | K971253 | 000 |
| 00885556606636 | K971253 | 000 |
| 00885556606629 | K971253 | 000 |
| 00885556606612 | K971253 | 000 |
| 00885556606605 | K971253 | 000 |
| 00885556606599 | K971253 | 000 |
| 00885556606582 | K971253 | 000 |
| 00885556606575 | K971253 | 000 |
| 00885556606322 | K971253 | 000 |
| 00885556606261 | K971253 | 000 |
| 03596010122230 | K971253 | 000 |