K063688 is an FDA 510(k) clearance for the SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE. This device is classified as a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I - General Controls, product code HWE).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 16, 2007, 35 days after receiving the submission on December 12, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K063688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2006 |
| Decision Date | January 16, 2007 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |