Cleared Traditional

K112208 - INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES

K112208 is an FDA 510(k) clearance for INTUTIVE SURGICAL DA VINCI SINGLE SITE ..., manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NAY cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K112208 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Dec 2011
Decision
129d
Days
Class 2
Risk

K112208 is an FDA 510(k) clearance for the INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES. 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 8, 2011 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

FDA 510(k) Submission Details - K112208

510(k) Number K112208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 01, 2011
Decision Date December 08, 2011
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NAY Device Classification - Class 2, Special Controls

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 164
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K112208.
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