VICO MICRO SURGICAL INSTRUMENTS— 510(k) K843592

Name: FDA 510(k) clearance K843592
Creator: U.S. Food and Drug Administration
Published: 1984-10-05

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K843592 for VICO MICRO SURGICAL INSTRUMENTS, Substantially Equivalent on 1984-10-05. Applicant: Visitec Co.. Device class: 1.

Clearance details

Applicant: Visitec Co.
Product code: Code HWQ
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1984-09-12
Decision date: 1984-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWQ

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K970360 — MITEK SUTURE RETROGRADER1997-03-10
K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE1993-05-05
K923381 — SOFT TISSUE EXPANDER1993-05-05
K885311 — MENISCUS MENDER II LOOP1989-02-09
K841622 — SOFT-TISSUE INSTRUMENT1984-07-11

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 HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

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.