STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS— 510(k) K951666

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K951666 for STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS, Substantially Equivalent on 1995-09-19. Applicant: Stryker Instruments.

Clearance details

Applicant: Stryker Instruments
Product code: Code FQH
Advisory panel: General Hospital
Date received: 1995-04-10
Decision date: 1995-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.