K935064 is an FDA 510(k) clearance for the ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION. 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 January 3, 1994, 75 days after receiving the submission on October 20, 1993.
This device falls under the Gastroenterology & Urology 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 | K935064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| 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. |