Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038182369

FEI Number

3038182369

Entity Name

INTUITIVE SURGICAL, INC.

City/State/Country

Santa Clara, CA, US

Establishment Address

3859 Kifer Road, --, Santa Clara, CA 95051, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Intuitive Surgical, Inc. (Owner Number: 9028901)

Owner / Operator Contact Address

1266 Kifer Road, --, Sunnyvale, CA 94086, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212048

PMA Number

N/A

All Registered Proprietary Names

Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) Ion Fully Articulating Catheter Reprocessing Cover Catheter Guide Leak Test Adapter Controller Vision Probe Adapter and Suction Adapter Catheter Continuity Cable Ion Fully Articulating Catheter Flexision Biopsy Needle 23G Ion Peripheral Vision Probe PlanPoint Software Catheter Continuity Stand Flexision Biopsy Needle 21G Bath Probe Planning Laptop Swivel Connector System Cart Flexision Biopsy Needle 19G Ion Reprocessing Consumable Kit Ion Endoluminal System (IF1000) Ion Peripheral Vision Probe Ion Fully Articulating Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-04-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-02-27
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-09-24
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-09-09

Official Correspondent

Ted Claiborne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intuitive Surgical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013942591	INTUITIVE SURGICAL, INC.	Sunnyvale, CA, US
3038188839	Intuitive Surgical Bulgaria EOOD	Parvomay Plovdiv, BG
2955842	INTUITIVE SURGICAL, INC.	SUNNYVALE, CA, US
3017119401	Intuitive Surgical Optics GmbH	Emmendingen Baden-Wurttemberg, DE
3042953929	Intuitive Solutions	Carrollton, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
3015970743	CENTERPOINT SYSTEMS LLC	West Valley City, UT, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038182369. Last updated year: 2026. Please use registration number 3038182369 when referencing this establishment in official correspondence.