Cleared Traditional

K050027 - LAPAROCISION SCOPE CONTROLLER SYSTEM

K050027 is an FDA 510(k) clearance for LAPAROCISION SCOPE CONTROLLER SYSTEM, manufactured by Gmp/Companies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K050027 · Gmp/Companies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
21d
Days
Class 2
Risk

K050027 is an FDA 510(k) clearance for the LAPAROCISION SCOPE CONTROLLER SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Gmp/Companies, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on January 27, 2005 after a review of 21 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 - K050027

510(k) Number K050027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2005
Decision Date January 27, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1429
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K050027.
ENDOLINK TRUE MOVEMENT SYSTEM
K043541 · Novare Surgical Systems, Inc. · Mar 2005
ENDOASSIST
K043284 · Armstrong Healthcare Limited · Feb 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · Micromedics, Inc. · Feb 2005
MD-6W WIRELESS CRITICAL DATA VIEWER
K042923 · The Microoptical Corporation · Dec 2004
GENICON SUCTION IRRIGATION SYSTEM
K041967 · Genicon · Nov 2004
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
K042069 · Acmi Corporation · Nov 2004

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K050027 · LAPAROCISION SCOPE CONTROLLER SYSTEM
Download PDF FDA Summary Gmp/Companies, Inc.