K002546 is an FDA 510(k) clearance for the CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on October 31, 2000, 75 days after receiving the submission on August 17, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K002546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2000 |
| Decision Date | October 31, 2000 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |