K913964 is an FDA 510(k) clearance for the MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS, a Forceps (Class I — General Controls, product code HTD), submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on October 23, 1991, 48 days after receiving the submission on September 5, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K913964 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 1991 |
| Decision Date | October 23, 1991 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HTD — Forceps |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |