37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN— 510(k) K851790

Name: FDA 510(k) clearance K851790
Creator: U.S. Food and Drug Administration
Published: 1985-05-23

Substantially Equivalent

Artiberia

FDA 510(k) clearance K851790 for 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN, Substantially Equivalent on 1985-05-23. Applicant: Artiberia. Device class: 1.

Clearance details

Applicant: Artiberia
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
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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K881669 — MVR/STILETTO BLADE 20GA. - P/N 19001988-05-13
K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE1988-04-13

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K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B1985-08-29
K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF1985-07-09
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 HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.