STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK— 510(k) K972069
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K972069 for STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK, Substantially Equivalent on 1997-07-29. Applicant: Stryker Instruments. Device class: 2.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code FQH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5475
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Recent devices under product code FQH
view allMore clearances from Stryker Instruments
view all- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K262244 — Sonopet iQ Series III Console (5700-050-000) +6 more
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261544 — Hydro Irrigation System
- K253679 — Hydro Irrigation System
Adverse events under product code FQH
product code FQH- Injury
- 170
- Malfunction
- 2,513
- Other
- 1
- Total
- 2,684
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.