K033728 is an FDA 510(k) clearance for the TRANSVAGINAL ENDOSCOPY SET. This device is classified as a Culdoscope (and Accessories) (Class II - Special Controls, product code HEW).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on February 27, 2004, 91 days after receiving the submission on November 28, 2003.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1640.
| 510(k) Number | K033728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2003 |
| Decision Date | February 27, 2004 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEW — Culdoscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1640 |