K121139 is an FDA 510(k) clearance for the ACCUMESH DEPLOYMENT SYSTEM. This device is classified as a Mesh, Surgical, Deployer (Class II - Special Controls, product code ORQ).
Submitted by Covidien, LLC (Bedford, US). The FDA issued a Cleared decision on May 2, 2012, 16 days after receiving the submission on April 16, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair)..
| 510(k) Number | K121139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2012 |
| Decision Date | May 02, 2012 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ORQ — Mesh, Surgical, Deployer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair). |