53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN— 510(k) K851798

Name: FDA 510(k) clearance K851798
Creator: U.S. Food and Drug Administration
Published: 1985-05-23

Substantially Equivalent

Artiberia

FDA 510(k) clearance K851798 for 53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN, Substantially Equivalent on 1985-05-23. Applicant: Artiberia. Device class: 2.

Clearance details

Applicant: Artiberia
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1985-04-25
Decision date: 1985-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B1985-08-29
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K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES1985-07-02
K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS1985-07-02
K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS1985-07-02

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.