INDISCAL ASPIRATION DEVICE AND ACCESSORIES— 510(k) K092877

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K092877 for INDISCAL ASPIRATION DEVICE AND ACCESSORIES, Substantially Equivalent on 2009-11-17. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2009-09-18
Decision date: 2009-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

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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.