K090419 is an FDA 510(k) clearance for the SILS STITCH ENDOSCOPIC SUTURING DEVICE. This device is classified as a Endoscopic Tissue Approximation Device (Class II - Special Controls, product code OCW).
Submitted by Covidien Lp, Formerly Registered AS United States (North Haven, US). The FDA issued a Cleared decision on March 9, 2009, 19 days after receiving the submission on February 18, 2009.
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 | K090419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2009 |
| Decision Date | March 09, 2009 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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. |