K950639 is an FDA 510(k) clearance for the KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS. This device is classified as a Vaginoscope And Accessories (Class II - Special Controls, product code MOK).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 19, 1995, 126 days after receiving the submission on February 13, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K950639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1995 |
| Decision Date | June 19, 1995 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MOK — Vaginoscope And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1630 |