PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT— 510(k) K921095

Substantially Equivalent

Pacer Tool & Plastics, Inc.

FDA 510(k) clearance K921095 for PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT, Substantially Equivalent on 1992-04-29. Applicant: Pacer Tool & Plastics, Inc..

Clearance details

Applicant: Pacer Tool & Plastics, Inc.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1992-03-06
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Plainfield, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.