K010184 is an FDA 510(k) clearance for the CHESS HAND SURGERY SYSTEM. This device is classified as a Instrument, Manual, Surgical, General Use (Class I - General Controls, product code MDM).
Submitted by Canica Design, Inc. (Almonte, Ontario, CA). The FDA issued a Cleared decision on June 22, 2001, 154 days after receiving the submission on January 19, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K010184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2001 |
| Decision Date | June 22, 2001 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MDM — Instrument, Manual, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |