RETRACTIVE INCISION MICROMETER (RIM) GUAGE— 510(k) K882402

Name: FDA 510(k) clearance K882402
Creator: U.S. Food and Drug Administration
Published: 1988-08-22

Substantially Equivalent

Optical Center

FDA 510(k) clearance K882402 for RETRACTIVE INCISION MICROMETER (RIM) GUAGE, Substantially Equivalent on 1988-08-22. Applicant: Optical Center. Device class: 1.

Clearance details

Applicant: Optical Center
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1988-06-10
Decision date: 1988-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, 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
K881669 — MVR/STILETTO BLADE 20GA. - P/N 19001988-05-13
K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE1988-04-13
K874057 — OPHTHALMIC TIP & BLADE SCALPELS1987-12-23

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.