Cleared Traditional

K990144 - INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS

K990144 is the FDA 510(k) clearance for INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS 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 539-day FDA review.

K990144 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Jul 2000
Decision
539d
Days
Class 2
Risk

K990144 is an FDA 510(k) clearance for the INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INST.... Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 11, 2000 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K990144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date July 11, 2000
Days to Decision 539 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
424d slower than avg
Panel avg: 115d · This submission: 539d
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.