K023411 is an FDA 510(k) clearance for the STEELEX STERNUM SET. This device is classified as a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II - Special Controls, product code GAQ).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 19, 2002, 69 days after receiving the submission on October 11, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4495.
| 510(k) Number | K023411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2002 |
| Decision Date | December 19, 2002 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4495 |