Submission Details
| 510(k) Number | K120752 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2012 |
| Decision Date | June 08, 2012 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
AERODR STITCHING SYSTEM
Jun 2012
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K120752 is an FDA 510(k) clearance for the AERODR STITCHING SYSTEM, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Konica Minolta Medical & Graphic, Inc. (New York, US). The FDA issued a Cleared decision on June 8, 2012, 88 days after receiving the submission on March 12, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
Manufacturer
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