Cleared Traditional

K050369 - INTUITIVE SURGICAL DA VINCI SURGICAL SY...

K050369 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 Traditional 510(k) pathway after a 74-day FDA review.

K050369 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Apr 2005
Decision
74d
Days
Class 2
Risk

K050369 is an FDA 510(k) clearance for the INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000. 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 April 29, 2005 after a review of 74 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 Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K050369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date April 29, 2005
Days to Decision 74 days
Submission Type Traditional
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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050369.
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
K061260 · Intuitive Surgical, Inc. · May 2006
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
K060391 · Intuitive Surgical, Inc. · Apr 2006
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050802 · Intuitive Surgical, Inc. · Jun 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 DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
K043153 · Intuitive Surgical, Inc. · Dec 2004