K153089 is an FDA 510(k) clearance for the 'cottony' II TAPE, PLEDGETS. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 12, 2016, 291 days after receiving the submission on October 26, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K153089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2015 |
| Decision Date | August 12, 2016 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT — Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |