Cleared Special

K052740 - NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM

K052740 is an FDA 510(k) clearance for NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM, manufactured by Conmed Integrated Systems (Cmis). The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 17-day FDA review.

K052740 · Conmed Integrated Systems (Cmis) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
17d
Days
Class 2
Risk

K052740 is an FDA 510(k) clearance for the NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Conmed Integrated Systems (Cmis) (Beaverton, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 17 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 Conmed Integrated Systems (Cmis) devices

FDA 510(k) Submission Details - K052740

510(k) Number K052740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2005
Decision Date October 17, 2005
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 928
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K052740.
MODULAR TROCAR SYSTEM
K060096 · Applied Medical Resources Corp. · Jan 2006
SPECIMEN RETRIEVAL SYSTEM
K060051 · Applied Medical Resources Corp. · Jan 2006
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · Smith & Nephew, Inc. · Nov 2005
F-400 SYSTEM
K051585 · Mauna Kea Technologies · Sep 2005
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc. · Aug 2005
ARMAND ENDOSCOPE HOLDER
K050051 · KLS-Martin L.P. · May 2005