STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK— 510(k) K972069

Substantially Equivalent

Stryker 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.

Clearance details

Applicant: Stryker Instruments
Product code: Code FQH
Advisory panel: General Hospital
Date received: 1997-06-03
Decision date: 1997-07-29
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.