K972069 is an FDA 510(k) clearance for the STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK. 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 July 29, 1997, 56 days after receiving the submission on June 3, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K972069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1997 |
| Decision Date | July 29, 1997 |
| Days to Decision | 56 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 |