K820837 is an FDA 510(k) clearance for the DISPOSABLE MULTIPLE LIGATING CLIP. This device is classified as a Applier, Surgical, Clip (Class I - General Controls, product code GDO).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 63 days after receiving the submission on March 26, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K820837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDO — Applier, Surgical, Clip |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |