Cleared Special

K120215 - SINGLE-SITE MEDIUM-LARGE CLIP APPLIER

K120215 is the FDA 510(k) clearance for SINGLE-SITE MEDIUM-LARGE CLIP APPLIER 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 97-day FDA review.

K120215 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Apr 2012
Decision
97d
Days
Class 2
Risk

K120215 is an FDA 510(k) clearance for the SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SI.... 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 30, 2012 after a review of 97 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. 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. Standard predicate reliance. 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 K120215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 24, 2012
Decision Date April 30, 2012
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 158
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K120215.
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
K123463 · Intuitive Surgical, Inc. · Dec 2012
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
K121921 · Intuitive Surgical, Inc. · Oct 2012
ENDOWRIST STAPLER SYSTEM
K113706 · Intuitive Surgical, Inc. · Oct 2012
ENDOWRIST ONE VESSEL SEALER
K110639 · Intuitive Surgical, Inc. · Dec 2011
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
K112208 · Intuitive Surgical, Inc. · Dec 2011
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
K112263 · Intuitive Surgical, Inc. · Oct 2011