PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT— 510(k) K934077

Substantially Equivalent

Phx Technologies Corp.

FDA 510(k) clearance K934077 for PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT, Substantially Equivalent on 1994-01-25. Applicant: Phx Technologies Corp..

Clearance details

Applicant: Phx Technologies Corp.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-20
Decision date: 1994-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.