MIST ENDOSCOPIC NEEDLES— 510(k) K951648

Substantially Equivalent

Mist, Inc.

FDA 510(k) clearance K951648 for MIST ENDOSCOPIC NEEDLES, Substantially Equivalent on 1995-05-12. Applicant: Mist, Inc..

Clearance details

Applicant: Mist, Inc.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-10
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.