Submission Details
| 510(k) Number | K061025 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 13, 2006 |
| Decision Date | May 31, 2006 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
ACCUTECH ENDOLITE PROBE
May 2006
Decision
48d
Days
Class 2
Risk
About This 510(k) Submission
K061025 is an FDA 510(k) clearance for the ACCUTECH ENDOLITE PROBE, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Accutech Medical Technologies, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 31, 2006, 48 days after receiving the submission on April 13, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | FFS — Image, Illumination, Fiberoptic, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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