KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA— 510(k) K850049

Name: FDA 510(k) clearance K850049
Creator: U.S. Food and Drug Administration
Published: 1985-03-06

Substantially Equivalent

Xtal Corp.

FDA 510(k) clearance K850049 for KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA, Substantially Equivalent on 1985-03-06. Applicant: Xtal Corp.. Device class: 1.

Clearance details

Applicant: Xtal Corp.
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-01-08
Decision date: 1985-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malverne, PA, 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

More clearances from Xtal Corp.

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K861163 — XTAL X-800 SHADOWGRAPH1986-05-06
K853855 — XTAL X-150 OPERATING MICROSCOPE1985-10-15

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.