SURGICAL KNIFE— 510(k) K834546

Name: FDA 510(k) clearance K834546
Creator: U.S. Food and Drug Administration
Published: 1984-03-16

Substantially Equivalent

Fine-Cut Diamond Instruments

FDA 510(k) clearance K834546 for SURGICAL KNIFE, Substantially Equivalent on 1984-03-16. Applicant: Fine-Cut Diamond Instruments. Device class: 1.

Clearance details

Applicant: Fine-Cut Diamond Instruments
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1983-12-27
Decision date: 1984-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HNN

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K110166 — CLEARCUT S SAFETY KNIFE2011-05-20
K922378 — OPHTHALMIC KNIFE1992-12-10
K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE1988-08-22
K881669 — MVR/STILETTO BLADE 20GA. - P/N 19001988-05-13
K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE1988-04-13

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.