Cleared Traditional

K922083 - RMI SURGICCAL SITE VISUALIZATION WAND

K922083 is the FDA 510(k) clearance for RMI SURGICCAL SITE VISUALIZATION WAND by Research Medical, Inc.. It is a Class 2 General Hospital device (product code FQH) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K922083 · Research Medical, Inc. · General Hospital
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Jan 1993
Decision
270d
Days
Class 2
Risk

K922083 is an FDA 510(k) clearance for the RMI SURGICCAL SITE VISUALIZATION WAND. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on January 29, 1993 after a review of 270 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Research Medical, Inc. devices

Submission Details

510(k) Number K922083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date January 29, 1993
Days to Decision 270 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 129d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 23
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K922083.
ARTISAN PULSE LAVAGE SYSTEM
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K951666 · Stryker Instruments · Sep 1995
EXCEL PULSED IRRIGATION/SUCTION SYSTEM
K873466 · Stryker Corp. · Nov 1987
DAVOL SURGICAL SUCTION IRRIGATION INSTR
K830386 · C.R. Bard, Inc. · Mar 1983
XOMED MICRO-IRRIGATOR
K813475 · Xomed, Inc. · Feb 1982