Cleared Special

K072715 - REALHAND HIGH DEXTERITY INSTRUMENTS

K072715 is an FDA 510(k) clearance for REALHAND HIGH DEXTERITY INSTRUMENTS, manufactured by Novare Surgical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 21-day FDA review.

K072715 · Novare Surgical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
21d
Days
Class 2
Risk

K072715 is an FDA 510(k) clearance for the REALHAND HIGH DEXTERITY INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Novare Surgical Systems, Inc. (Concord, US). The FDA issued a Cleared decision on October 16, 2007 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. 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.

View all Novare Surgical Systems, Inc. devices

FDA 510(k) Submission Details - K072715

510(k) Number K072715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2007
Decision Date October 16, 2007
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
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 950
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K072715.
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K080155 · Intuitive Surgical, Inc. · Mar 2008
ONEPORT SURGICAL TROCAR SYSTEM
K073009 · Conmed Corporation · Dec 2007
SOPRO 225 DUAL HALOGEN LIGHT SOURCE
K072912 · Sopro · Nov 2007
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