DECHERNEY HYSTEROSCOPY PUMP SYSTEM— 510(k) K873527

Substantially Equivalent

Cabot Medical Corp.

FDA 510(k) clearance K873527 for DECHERNEY HYSTEROSCOPY PUMP SYSTEM, Substantially Equivalent on 1988-02-26. Applicant: Cabot Medical Corp..

Clearance details

Applicant: Cabot Medical Corp.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1987-09-01
Decision date: 1988-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.