VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM— 510(k) K992876

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K992876 for VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM, Substantially Equivalent on 1999-09-24. Applicant: Mitek Products.

Clearance details

Applicant: Mitek Products
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1999-08-26
Decision date: 1999-09-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Westwood, MA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.