K771181 is an FDA 510(k) clearance for the VAGINAL ILLUMINATOR, MODEL 78570. This device is classified as a Speculum, Vaginal, Metal, Fiberoptic (Class I - General Controls, product code HDG).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977, 14 days after receiving the submission on June 30, 1977.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4520.
| 510(k) Number | K771181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1977 |
| Decision Date | July 14, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HDG — Speculum, Vaginal, Metal, Fiberoptic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4520 |