Cleared Special

K120215 - SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE

K120215 is an FDA 510(k) clearance for SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NAY cleared through the Special 510(k) pathway after a 97-day FDA review.

K120215 · Intuitive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K120215

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.

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 165
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
K120215 · SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
Download PDF FDA Summary Intuitive Surgical, I…