Cleared Traditional

K843592 - VICO MICRO SURGICAL INSTRUMENTS

K843592 is an FDA 510(k) clearance for VICO MICRO SURGICAL INSTRUMENTS, manufactured by Visitec Co.. The device is a Class 1 Orthopedic device with product code HWQ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K843592 · Visitec Co. · Orthopedic device
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Oct 1984
Decision
23d
Days
Class 1
Risk

K843592 is an FDA 510(k) clearance for the VICO MICRO SURGICAL INSTRUMENTS. Classified as Passer (product code HWQ), Class I - General Controls.

Submitted by Visitec Co. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Visitec Co. devices

FDA 510(k) Submission Details - K843592

510(k) Number K843592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date October 05, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

HWQ Device Classification - Class 1, General Controls

Product Code HWQ Passer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWQ Passer

Devices cleared under the same product code (HWQ) and FDA review panel - the closest regulatory comparables to K843592.
ACUFEX PASSING PINS AND SURGICAL WIRE
K920621 · Acufex Microsurgical, Inc. · May 1993
SOFT TISSUE EXPANDER
K923381 · Acufex Microsurgical, Inc. · May 1993
MENISCUS MENDER II LOOP
K885311 · Instrument Makar, Inc. · Feb 1989
SILASTIC TENDON PASSER H.P.
K811679 · Dow Corning Corp. Healthcare Industries Materials · Jul 1981
ROTH-KENNEDY PASSER
K791960 · 3M Company · Oct 1979