PARACERVICAL/PUDENDAL TRAYS— 510(k) K896799

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896799 for PARACERVICAL/PUDENDAL TRAYS, Substantially Equivalent on 1990-04-23. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps).

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1989-12-01
Decision date: 1990-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.