K913772 is an FDA 510(k) clearance for the PRESSURE GUARD. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Beacon Laboratories, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 19, 1991, 88 days after receiving the submission on August 23, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K913772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1991 |
| Decision Date | November 19, 1991 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |