K925526 is an FDA 510(k) clearance for the MANIPLER DISPOSABLE SKIN STAPLER. This device is classified as a Staple, Removable (skin) (Class I - General Controls, product code GDT).
Submitted by Matsutani Seisakusho Co. , Ltd. (Mahwah, US). The FDA issued a Cleared decision on June 24, 1993, 234 days after receiving the submission on November 2, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4760.
| 510(k) Number | K925526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1992 |
| Decision Date | June 24, 1993 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDT — Staple, Removable (skin) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4760 |