Cleared Special

REALHAND HIGH DEXTERITY (HD) INSTRUMENTS (K071488) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071488 · Novare Surgical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
30d
Days
Class 2
Risk

K071488 is an FDA 510(k) clearance for the REALHAND HIGH DEXTERITY (HD) INSTRUMENTS. 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 June 29, 2007 after a review of 30 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

Submission Details

510(k) Number K071488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2007
Decision Date June 29, 2007
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1420
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K071488.
TroKit Laparoscope Lens Wiper
K253994 · TroCare, LLC · Jun 2026
Inno-Port Disposable Bladed Trocar
K252532 · Taiwan Surgical Corporation · Jun 2026
4K NIR/ICG Imaging System
K260318 · Zhejiang Healnoc Technology Co., Ltd. · May 2026
MediBot Needle Driver Uno
K260183 · Parallel Robotics, LLC · May 2026
Laport
K252985 · Sejong Medical Co., Ltd. · May 2026
KARL STORZ Trocars with Valve Seals
K254228 · Karl Storz SE & CO. KG · May 2026