K052387 is an FDA 510(k) clearance for the ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX. This device is classified as a Finger Cot (Class I - General Controls, product code LZB).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 29, 2005, 90 days after receiving the submission on August 31, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K052387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2005 |
| Decision Date | November 29, 2005 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZB — Finger Cot |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |