Cleared Traditional

K203632 - da Vinci S/Si (IS2000/IS3000) 5mm and 8...

K203632 is an FDA 510(k) clearance for da Vinci S/Si (IS2000/IS3000) 5mm and 8..., manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NAY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K203632 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Feb 2021
Decision
61d
Days
Class 2
Risk

K203632 is an FDA 510(k) clearance for the da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X.... 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 10, 2021 after a review of 61 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

FDA 510(k) Submission Details - K203632

510(k) Number K203632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2020
Decision Date February 10, 2021
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 161
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K203632.
da Vinci SP Surgical System (SP1098)
K211595 · Intuitive Surgical, Inc. · Jun 2021
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K210918 · Intuitive Surgical, Inc. · Apr 2021
Senhance Surgical System
K202166 · Transenterix, Inc. · Mar 2021
SoloAsisst II, Voice Control
K200473 · Aktormed GmbH · Dec 2020
Da Vinci SP Surgical System
K202968 · Intuitive Surgical, Inc. · Dec 2020
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K202834 · Intuitive Surgical, Inc. · Dec 2020