Cleared Traditional

K101743 - 5MM FLARED CANNULA MODEL 420262

K101743 is the FDA 510(k) clearance for 5MM FLARED CANNULA MODEL 420262 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 227-day FDA review.

K101743 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Feb 2011
Decision
227d
Days
Class 2
Risk

K101743 is an FDA 510(k) clearance for the 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319. 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 February 4, 2011 after a review of 227 days - an extended review 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: 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

Submission Details

510(k) Number K101743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2010
Decision Date February 04, 2011
Days to Decision 227 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
112d slower than avg
Panel avg: 115d · This submission: 227d
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 158
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K101743.
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
K112584 · Intuitive Surgical, Inc. · Sep 2011
ENDOWRIST ONE SUCTION/IRRIGATOR
K110451 · Intuitive Surgical, Inc. · Aug 2011
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
K101581 · Intuitive Surgical, Inc. · Apr 2011
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
K093217 · Intuitive Surgical, Inc. · Jan 2010
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
K090993 · Intuitive Surgical, Inc. · Dec 2009
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
K082497 · Intuitive Surgical, Inc. · May 2009