Cleared Traditional

K043541 - ENDOLINK TRUE MOVEMENT SYSTEM

K043541 is an FDA 510(k) clearance for ENDOLINK TRUE MOVEMENT SYSTEM, manufactured by Novare Surgical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K043541 · Novare Surgical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
78d
Days
Class 2
Risk

K043541 is an FDA 510(k) clearance for the ENDOLINK TRUE MOVEMENT SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Novare Surgical Systems, Inc. (Lutsen, US). The FDA issued a Cleared decision on March 10, 2005 after a review of 78 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K043541

510(k) Number K043541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2004
Decision Date March 10, 2005
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 1428
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K043541.
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
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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
ENDOASSIST
K043284 · Armstrong Healthcare Limited · Feb 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · Micromedics, Inc. · Feb 2005
LAPAROCISION SCOPE CONTROLLER SYSTEM
K050027 · Gmp/Companies, Inc. · Jan 2005
K043541 · ENDOLINK TRUE MOVEMENT SYSTEM
Download PDF FDA Summary Novare Surgical Syste…