Cleared Traditional

K152421 - IS4000 Stapler 30 Instrument and Staple...

K152421 is the FDA 510(k) clearance for IS4000 Stapler 30 Instrument and Staple... 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 191-day FDA review.

K152421 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Mar 2016
Decision
191d
Days
Class 2
Risk

K152421 is an FDA 510(k) clearance for the IS4000 Stapler 30 Instrument and Stapler 30 Reloads. 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 March 4, 2016 after a review of 191 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 K152421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2015
Decision Date March 04, 2016
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
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 K152421.
da Vinci Xi Surgical System
K161271 · Intuitive Surgical, Inc. · Jul 2016
da Vinci Surgical System, Model IS4000
K152578 · Intuitive Surgical, Inc. · Mar 2016
da Vinci Single-Site Instrument and Accessories
K152448 · Intuitive Surgical, Inc. · Mar 2016
da Vinci Xi Surgical System
K151794 · Intuitive Surgical, Inc. · Jan 2016
IS4000 da Vinci EndoWrist Instruments
K150284 · Intuitive Surgical, Inc. · May 2015
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
K150837 · Intuitive Surgical, Inc. · Apr 2015