K911522 is an FDA 510(k) clearance for the ARTHROBOT(TM) WRIST HOLDER ACCESSORY. This device is classified as a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I - General Controls, product code JEA).
Submitted by Andronic Devices, Ltd. (Richmond,B.C. V6v-2j2, CA). The FDA issued a Cleared decision on April 29, 1991, 25 days after receiving the submission on April 4, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K911522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1991 |
| Decision Date | April 29, 1991 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JEA — Table, Surgical With Orthopedic Accessories, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |