Cleared Special

K043153 - INTUITIVE SURGICAL DA VINCI SURGICAL SY...

K043153 is the FDA 510(k) clearance for INTUITIVE SURGICAL DA VINCI SURGICAL SY... by Intuitive Surgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code NAY) cleared through the Special 510(k) pathway after a 30-day FDA review.

K043153 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Dec 2004
Decision
30d
Days
Class 2
Risk

K043153 is an FDA 510(k) clearance for the INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODEL.... Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 15, 2004 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 Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K043153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2004
Decision Date December 15, 2004
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
Combination Product No
PCCP Authorized No
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 NAY System, Surgical, Computer Controlled Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (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 - NAY System, Surgical, Computer Controlled Instrument

All 159
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K043153.
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
K050369 · Intuitive Surgical, Inc. · Apr 2005
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K043288 · Intuitive Surgical, Inc. · Mar 2005
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179
K050005 · Intuitive Surgical, Inc. · Jan 2005
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
K042855 · Intuitive Surgical, Inc. · Nov 2004
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K040237 · Intuitive Surgical, Inc. · Jul 2004
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
K040948 · Intuitive Surgical, Inc. · May 2004