OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE— 510(k) K853598

Name: FDA 510(k) clearance K853598
Creator: U.S. Food and Drug Administration
Published: 1985-11-04

Substantially Equivalent

Myocure, Inc.

FDA 510(k) clearance K853598 for OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE, Substantially Equivalent on 1985-11-04. Applicant: Myocure, Inc.. Device class: 1.

Clearance details

Applicant: Myocure, Inc.
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-08-27
Decision date: 1985-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, 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

More clearances from Myocure, Inc.

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K880345 — CYSTOTOMES/KNIFES1988-05-03
K880346 — CANNULAS1988-05-03
K880347 — ANESTHESIA/RETROBULBAR NEEDLES1988-05-03
K874057 — OPHTHALMIC TIP & BLADE SCALPELS1987-12-23
K874056 — OPHTHALMIC DISPOSABLE BLADES1987-12-22

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.