Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Endoscope Sterilization Tray

K-Number: K180964 · 2018-09-28

ApplicantIntuitive Surgical, Inc.
Decision Date2018-09-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Endoscope Sterilization Tray is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K180964. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscope Sterilization Tray?

Endoscope Sterilization Tray is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K180964.

When was Endoscope Sterilization Tray approved by the FDA?

Endoscope Sterilization Tray received FDA 510(k) clearance on 2018-09-28, under approval number K180964.

What company makes Endoscope Sterilization Tray?

Endoscope Sterilization Tray is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for Endoscope Sterilization Tray?

The FDA product code for Endoscope Sterilization Tray is KCT.

Other Devices by Intuitive Surgical, Inc.

K162411da Vinci Xi 12 – 8 mm Reducer K153276da Vinci Xi Surgical System K161271da Vinci Xi Surgical System K152578da Vinci Surgical System, Model IS4000 K152448da Vinci Single-Site Instrument and Accessories K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads

View all 107 devices →

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑