Cleared Traditional

K910218 - LAPAROMED CHOLANGIOGRAM VACUUM DEVICE

K910218 is an FDA 510(k) clearance for LAPAROMED CHOLANGIOGRAM VACUUM DEVICE, manufactured by Laparomed Corp.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K910218 · Laparomed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
81d
Days
Class 2
Risk

K910218 is an FDA 510(k) clearance for the LAPAROMED CHOLANGIOGRAM VACUUM DEVICE. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Laparomed Corp. (Irvine, US). The FDA issued a Cleared decision on April 8, 1991 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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: 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 Laparomed Corp. devices

FDA 510(k) Submission Details - K910218

510(k) Number K910218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1991
Decision Date April 08, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 47
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K910218.
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726 · Stryker Endoscopy · Nov 1995
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337 · Deknatel, Inc. · Jul 1993
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
K910377 · CooperSurgical, Inc. · Apr 1991
THORA-KLEX CHEST DRAINAGE UNIT
K905448 · Davol, Inc. · Mar 1991
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
MANIFOLD
K896804 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990