Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013596742

FEI Number

3013596742

Entity Name

EBR SYSTEMS INC.

City/State/Country

Sunnyvale, CA, US

Establishment Address

480 Oakmead Pkwy, Sunnyvale, CA 94085, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

EBR Systems Inc. (Owner Number: 10092727)

Owner / Operator Contact Address

480 Oakmead Parkway, Sunnyvale, CA 94085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterilization wrap Bottom Container Steam Sterilization Top Container Uterine Dilator Retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-04-30
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2025-04-30
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2025-04-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-02-11

Official Correspondent

Pharoah Garma

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EBR Systems 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
3044322716	EBR SYSTEMS INC.	Santa Clara, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013596742. Last updated year: 2026. Please use registration number 3013596742 when referencing this establishment in official correspondence.