INJECTION NEEDLE PROBE/DEVICE-TUNIS— 510(k) K983765

Substantially Equivalent

Ximed/Prosure/Injectx

FDA 510(k) clearance K983765 for INJECTION NEEDLE PROBE/DEVICE-TUNIS, Substantially Equivalent on 1998-12-11. Applicant: Ximed/Prosure/Injectx.

Clearance details

Applicant: Ximed/Prosure/Injectx
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-26
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.