Submission Details
| 510(k) Number | K000212 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
KSEA CHARDONNES MORCELLATION KNIFE
Apr 2000
Decision
88d
Days
Class 1
Risk
About This 510(k) Submission
K000212 is an FDA 510(k) clearance for the KSEA CHARDONNES MORCELLATION KNIFE, 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 review panel. Regulated under 21 CFR 884.4520.
Device Classification
| Product Code | KOH — Instrument, Manual, General Obstetric-gynecologic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 884.4520 |
Manufacturer
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