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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 the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) 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. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K180964.

When did Endoscope Sterilization Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for Endoscope Sterilization Tray?

The FDA 510(k) record lists Intuitive Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscope Sterilization Tray?

The FDA product code for Endoscope Sterilization Tray is KCT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Intuitive Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

View all 124 devices →

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

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