SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT— 510(k) K964450

Substantially Equivalent

Pilling Weck Group

FDA 510(k) clearance K964450 for SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT, Substantially Equivalent on 1997-01-10. Applicant: Pilling Weck Group.

Clearance details

Applicant: Pilling Weck Group
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1996-11-06
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.