K971188 is an FDA 510(k) clearance for the SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on June 27, 1997, 88 days after receiving the submission on March 31, 1997.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K971188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1997 |
| Decision Date | June 27, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |