N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110— 510(k) K043383

Substantially Equivalent

Physion, Inc.

FDA 510(k) clearance K043383 for N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110, Substantially Equivalent on 2005-10-27. Applicant: Physion, Inc..

Clearance details

Applicant: Physion, Inc.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2004-12-09
Decision date: 2005-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Short Hills, NJ, US

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Adverse events under product code FBK

product code FBK

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.