K153358 is an FDA 510(k) clearance for the Standard Clamp. This device is classified as a Clamp, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDJ).
Submitted by Standard Bariatrics (Cincinnati, US). The FDA issued a Cleared decision on May 2, 2016, 164 days after receiving the submission on November 20, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K153358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2015 |
| Decision Date | May 02, 2016 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDJ - Clamp, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |