Spirus Medical, LLC

FDA Device Registration & Listing · W Bridgewater, MA, US · Registration 3005814162

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005814162
FEI Number
3005814162
Entity Name
Spirus Medical, LLC
City/State/Country
W Bridgewater, MA, US
Establishment Address
375 West St, W Bridgewater, MA 02379, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Spirus Medical, LLC (Owner Number: 10022943)
Owner / Operator Contact Address
375 West St, West Bridgewater, MA 02379, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080042
PMA Number
N/A

All Registered Proprietary Names

Endo-Ease Advantage Endo-Ease Vista Endo-Ease Discovery SB Spirus Medical Lubricant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-10-24
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2009-11-12
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2009-11-12

Official Correspondent

Daniel Massucco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spirus Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26

Similar Registrations

Registration Number Establishment Name Location
3044858680 JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD. Shanghai, CN
3030511423 ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD. Hangzhou Zhejiang, CN
3011050570 Gyrus ACMI, Inc. Brooklyn Park, MN, US
3035480112 SEPLOU (ZHUHAI) CO.,LTD. Zhuhai Guangdong, CN
3012345110 Novadaq Technologies ULC Burnaby British Columbia, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005814162. Last updated year: 2026. Please use registration number 3005814162 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.