ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME— 510(k) K934315

Name: FDA 510(k) clearance K934315
Creator: U.S. Food and Drug Administration
Published: 1994-02-28

Substantially Equivalent

Endovations

FDA 510(k) clearance K934315 for ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME, Substantially Equivalent on 1994-02-28. Applicant: Endovations. Device class: 2.

Clearance details

Applicant: Endovations
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1993-09-01
Decision date: 1994-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

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K942110 — INJECT-SNARE1994-10-13
K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH1991-10-08
K913870 — 5MM MICROSCISSORS1991-09-16
K911155 — OVAL CUP BIOPSY FORCEP1991-08-07

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.