K043013 is an FDA 510(k) clearance for the MILTEX LAPAROSCOPIC INSTRUMENTS, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on March 4, 2005, 122 days after receiving the submission on November 2, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K043013 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2004 |
| Decision Date | March 04, 2005 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1720 |