Cleared Traditional

K142683 - 12 mm Endoscopes and Accessories

K142683 is an FDA 510(k) clearance for 12 mm Endoscopes and Accessories, manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General Hospital device with product code NAY cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K142683 · Intuitive Surgical, Inc. · General Hospital
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Dec 2014
Decision
82d
Days
Class 2
Risk

K142683 is an FDA 510(k) clearance for the 12 mm Endoscopes and Accessories. 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 December 10, 2014 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital 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 - K142683

510(k) Number K142683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date December 10, 2014
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
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 Hospital devices follow this clearance model.

Regulatory Peers - NAY System, Surgical, Computer Controlled Instrument

All 163
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K142683.
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K123329 · Intuitive Surgical, Inc. · Sep 2014