K003949 is an FDA 510(k) clearance for the TACKER, MODEL R65-933, a Endoscopic Tissue Approximation Device (Class II — Special Controls, product code OCW), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 25, 2001, 216 days after receiving the submission on December 21, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K003949 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 21, 2000 |
| Decision Date | July 25, 2001 |
| Days to Decision | 216 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. |