K951666 is an FDA 510(k) clearance for the STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on September 19, 1995, 162 days after receiving the submission on April 10, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K951666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1995 |
| Decision Date | September 19, 1995 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |