Cleared Special

K063457 - TRUEHD (1080P) DIGITAL CAMERA SYSTEM

K063457 is an FDA 510(k) clearance for TRUEHD (1080P) DIGITAL CAMERA SYSTEM, manufactured by Conmed Linvatec. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 20-day FDA review.

K063457 · Conmed Linvatec · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
20d
Days
Class 2
Risk

K063457 is an FDA 510(k) clearance for the TRUEHD (1080P) DIGITAL CAMERA SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on December 5, 2006 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063457

510(k) Number K063457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date December 05, 2006
Days to Decision 20 days
Submission Type Special
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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K063457.
SOPRO 162 CAMERA
K070102 · Sopro · Feb 2007
TROCASYS
K063528 · PAJUNK GmbH Medizintechnologie · Jan 2007
LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES
K062968 · Medsys, S.A. · Jan 2007
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
K062727 · Medtronic Vascular · Oct 2006
BASX BLADELESS TROCAR
K062209 · Ethicon Endo-Surgery, LLC · Oct 2006
DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP)
K062779 · New Wave Surgical Corporation · Oct 2006
K063457 · TRUEHD (1080P) DIGITAL CAMERA SYSTEM
Download PDF FDA Summary Conmed Linvatec