K891037 is an FDA 510(k) clearance for the WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE. This device is classified as a Washer, Endometrial (Class II - Special Controls, product code HFD).
Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 17, 1989, 17 days after receiving the submission on February 28, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1185.
| 510(k) Number | K891037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1989 |
| Decision Date | March 17, 1989 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFD — Washer, Endometrial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1185 |