K935503 is an FDA 510(k) clearance for the DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 7, 1994, 111 days after receiving the submission on November 16, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K935503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1993 |
| Decision Date | March 07, 1994 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |