Submission Details
| 510(k) Number | K062659 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 2006 |
| Decision Date | March 09, 2007 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
Mar 2007
Decision
183d
Days
Class 2
Risk
About This 510(k) Submission
K062659 is an FDA 510(k) clearance for the KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES, a Unit, Cautery, Thermal, Battery-powered (Class II — Special Controls, product code HQP), submitted by Kirwan Surgical Products, Inc. (Marshfield, US). The FDA issued a Cleared decision on March 9, 2007, 183 days after receiving the submission on September 7, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4115.
Device Classification
| Product Code | HQP — Unit, Cautery, Thermal, Battery-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4115 |
Manufacturer
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