Cleared Traditional

K212101 - da Vinci SP Firefly Imaging System

K212101 is an FDA 510(k) clearance for da Vinci SP Firefly Imaging System, 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 140-day FDA review.

K212101 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Nov 2021
Decision
140d
Days
Class 2
Risk

K212101 is an FDA 510(k) clearance for the da Vinci SP Firefly Imaging System. 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 November 23, 2021 after a review of 140 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. 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

FDA 510(k) Submission Details - K212101

510(k) Number K212101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2021
Decision Date November 23, 2021
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 K212101.
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K213710 · Intuitive Surgical, Inc. · Feb 2022
8mm Monopolar Curved Scissors
K220023 · Intuitive Surgical, Inc. · Jan 2022
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
K211997 · Intuitive Surgical, Inc. · Dec 2021
Da Vinci SP Surgical System
K212747 · Intuitive Surgical, Inc. · Sep 2021
Senhance Surgical System
K212054 · Asensus Surgical, Inc. · Aug 2021
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K211784 · Intuitive Surgical, Inc. · Aug 2021