Submission Details
| 510(k) Number | K070836 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 2007 |
| Decision Date | April 20, 2007 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
EXICLIP EXCS-M
Apr 2007
Decision
24d
Days
Class 1
Risk
About This 510(k) Submission
K070836 is an FDA 510(k) clearance for the EXICLIP EXCS-M, a Device, Percutaneous, Biopsy (Class I — General Controls, product code MJG), submitted by Clevex, Inc. (Loveland, US). The FDA issued a Cleared decision on April 20, 2007, 24 days after receiving the submission on March 27, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
Device Classification
| Product Code | MJG — Device, Percutaneous, Biopsy |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |
Manufacturer
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