K931379 is an FDA 510(k) clearance for the MICROVASIVE INSURG LAPTIE SUTURE LIGATOR. This device is classified as a Instrument, Ligature Passing And Knot Tying (Class I - General Controls, product code HCF).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on July 13, 1993, 117 days after receiving the submission on March 18, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K931379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1993 |
| Decision Date | July 13, 1993 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HCF — Instrument, Ligature Passing And Knot Tying |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |