Endoscope Sterilization Tray— 510(k) K183139

Name: FDA 510(k) clearance K183139
Creator: U.S. Food and Drug Administration
Published: 2019-02-01

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K183139 for Endoscope Sterilization Tray, Substantially Equivalent on 2019-02-01. Applicant: Intuitive Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2018-11-13
Decision date: 2019-02-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K183139

K-number listed on FDA's recall record

Z-2328-2020 — STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.Class II·Terminated·Intuitive Surgical, Inc.·20191219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183139.

Data sourced from openFDA. This site is unofficial and independent of the FDA.