K870897 is an FDA 510(k) clearance for the KODNER ANAL PERIONEAL RETRACTOR. This device is classified as a Retractor, Self-retaining (Class I - General Controls, product code FFO).
Submitted by Sur-Med Instruments, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 4, 1987, 91 days after receiving the submission on March 5, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K870897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1987 |
| Decision Date | June 04, 1987 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFO — Retractor, Self-retaining |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |