Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007389669

FEI Number

3007389669

Entity Name

Algram Group Ltd

City/State/Country

Plymouth Devon, GB

Establishment Address

Eastern Wood Road, Langage Industrial Estate, Plympton, Plymouth Devon PL7 5ET, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033222

PMA Number

N/A

All Registered Proprietary Names

MAJ-1651 MAJ-1681 MAJ-1606 MAJ-1603 MAJ-1607 OFP-2 MAJ-1608 MAJ-1652 MAJ-1682 MA-651 MAJ-1632 MB-142 MA-392 MA-474 OLYMPUS STERILIZATION TRAYS Olympus KeyMed Instrument Tray A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2023-10-20
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-10-20
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2016-02-23
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

OLYMPUS CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004450998	Gyrus ACMI, Inc.	Redmond, WA, US
9611174	KEYMED (Medical & Industrial Equipment) Ltd	SOUTHEND-ON-SEA Essex, GB
3010590422	QUEST MEDICAL IMAGING	Wieringerwerf Noord-Holland, NL
3031983124	ODIN MEDICAL LIMITED	London London, City of, GB
3003724334	Olympus Winter & Ibe GmbH	TELTOW Brandenburg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

Registration Number	Establishment Name	Location
3013348547	CIPHER SURGICAL LTD	Coventry, GB
9681260	Boston Scientific Limited	GALWAY, IE
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007389669. Last updated year: 2026. Please use registration number 3007389669 when referencing this establishment in official correspondence.