MICROSURGERY KNIFE— 510(k) K820618

Name: FDA 510(k) clearance K820618
Creator: U.S. Food and Drug Administration
Published: 1982-04-09

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K820618 for MICROSURGERY KNIFE, Substantially Equivalent on 1982-04-09. Applicant: Visitec Co.. Device class: 1.

Clearance details

Applicant: Visitec Co.
Product code: Code HNN
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1982-03-08
Decision date: 1982-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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 Visitec Co.

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K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}1995-10-12
K945114 — VISITEC SCLERAL PLUG1995-02-23
K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE1995-02-14
K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS1995-01-17
K942234 — VISITEC PRECISE-POINT1994-07-12

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.