Submission Details
| 510(k) Number | K122605 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2012 |
| Decision Date | December 05, 2012 |
| Days to Decision | 100 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
PKS BILL
Dec 2012
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K122605 is an FDA 510(k) clearance for the PKS BILL, a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II — Special Controls, product code HIN), submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on December 5, 2012, 100 days after receiving the submission on August 27, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4150.
Device Classification
| Product Code | HIN — Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4150 |
Manufacturer
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