Cleared Traditional

K043284 - ENDOASSIST

K043284 is an FDA 510(k) clearance for ENDOASSIST, manufactured by Armstrong Healthcare Limited. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K043284 · Armstrong Healthcare Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
91d
Days
Class 2
Risk

K043284 is an FDA 510(k) clearance for the ENDOASSIST. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Armstrong Healthcare Limited (High Wycombe, GB). The FDA issued a Cleared decision on February 25, 2005 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Armstrong Healthcare Limited devices

FDA 510(k) Submission Details - K043284

510(k) Number K043284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date February 25, 2005
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1175
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K043284.
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
K050639 · Lumenis, Inc. · Mar 2005
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
K050163 · Henke Sass Wolf of America, Inc. · Mar 2005
ENDOLINK TRUE MOVEMENT SYSTEM
K043541 · Novare Surgical Systems, Inc. · Mar 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · Micromedics, Inc. · Feb 2005
LAPAROCISION SCOPE CONTROLLER SYSTEM
K050027 · Gmp/Companies, Inc. · Jan 2005
MD-6W WIRELESS CRITICAL DATA VIEWER
K042923 · The Microoptical Corporation · Dec 2004