K934174 is an FDA 510(k) clearance for the LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER. This device is classified as a Endoscopic Tissue Approximation Device (Class II - Special Controls, product code OCW).
Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 9, 1994, 194 days after receiving the submission on August 27, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue..
| 510(k) Number | K934174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1993 |
| Decision Date | March 09, 1994 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OCW — Endoscopic Tissue Approximation Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue. |