Cleared Traditional

K170508 - EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170508 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Mar 2017
Decision
17d
Days
Class 2
Risk

K170508 is an FDA 510(k) clearance for the EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stap.... 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 10, 2017 after a review of 17 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K170508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date March 10, 2017
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 114d · This submission: 17d
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 161
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