Cleared Traditional

K920643 - LAPAROSCOPIC SUCTION/IRRIGATION PROBE

K920643 is an FDA 510(k) clearance for LAPAROSCOPIC SUCTION/IRRIGATION PROBE, manufactured by O.R. Concepts, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K920643 · O.R. Concepts, Inc. · General & Plastic Surgery device
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May 1992
Decision
84d
Days
Class 1
Risk

K920643 is an FDA 510(k) clearance for the LAPAROSCOPIC SUCTION/IRRIGATION PROBE. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on May 6, 1992 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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: 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 O.R. Concepts, Inc. devices

FDA 510(k) Submission Details - K920643

510(k) Number K920643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date May 06, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

GBZ Device Classification - Class 1, General Controls

Product Code GBZ Catheter, Cholangiography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBZ Catheter, Cholangiography

All 12
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K920643.
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
CHOLANGIOGRAPHY CLAMP
K924480 · Applied Medical Resources · Mar 1993
CHOLANGIOGRAPHY CATHETER
K924128 · Applied Medical Resources · Feb 1993
CHOLANGIOLAPCATH(TM)
K921091 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP
K914015 · Pilling Co. · Nov 1991
MENTOR DUCTAL CATHETERS
K895285 · Mentor Corp. · Oct 1989