WINGED NEEDLE HOLDER— 510(k) K974327

Substantially Equivalent

Phx Technologies Corp.

FDA 510(k) clearance K974327 for WINGED NEEDLE HOLDER, Substantially Equivalent on 1998-01-09. Applicant: Phx Technologies Corp..

Clearance details

Applicant: Phx Technologies Corp.
Product code: Code FHQ
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-18
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, US

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Adverse events under product code FHQ

product code FHQ

Other: 1
Total: 1

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.