Cleared Traditional

K063859 - SURGIQUEST ELASTOMERIC OPTICAL TROCAR &...

K063859 is an FDA 510(k) clearance for SURGIQUEST ELASTOMERIC OPTICAL TROCAR &..., manufactured by Surgiquest, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K063859 · Surgiquest, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
76d
Days
Class 2
Risk

K063859 is an FDA 510(k) clearance for the SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Surgiquest, Inc. (Orange, US). The FDA issued a Cleared decision on March 14, 2007 after a review of 76 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.

View all Surgiquest, Inc. devices

FDA 510(k) Submission Details - K063859

510(k) Number K063859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date March 14, 2007
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
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 845
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K063859.
KII TROCAR SYSTEM
K072674 · Applied Medical Resources Corp. · Oct 2007
VIEW MD OFFICE SYSTEM, MODEL 41066.5540
K071292 · Richard Wolf Medical Instruments Corp. · Jul 2007
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02
K070198 · Ethicon Endo-Surgery, LLC · Jun 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · Smith & Nephew, Inc. · Feb 2007
SOPRO 162 CAMERA
K070102 · Sopro · Feb 2007
TROCASYS
K063528 · PAJUNK GmbH Medizintechnologie · Jan 2007