K000212 is an FDA 510(k) clearance for the KSEA CHARDONNES MORCELLATION KNIFE. This device is classified as a Instrument, Manual, General Obstetric-gynecologic (Class I - General Controls, product code KOH).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 21, 2000, 88 days after receiving the submission on January 24, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4520.
| 510(k) Number | K000212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2000 |
| Decision Date | April 21, 2000 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KOH — Instrument, Manual, General Obstetric-gynecologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4520 |