Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1723241

FEI Number

1000517719

Entity Name

GENESEE BIOMEDICAL, INC.

City/State/Country

DENVER, CO, US

Establishment Address

700 W Mississippi Ave Unit D5, DENVER, CO 80223, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GENESEE BIOMEDICAL, INC. (Owner Number: 9012312)

Owner / Operator Contact Address

700 W Mississippi Ave, Unit D-5, Denver, CO 80223, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K905067

PMA Number

N/A

All Registered Proprietary Names

Reusable Coronary Probes Thoracic Port Knot Pusher Aortic Valve Repair Tool Kit Suction Tubes Robotic Stainless Steel Valve Sizer Suture Hook Robotic Tool Kit HEART-LIFT CARDIAC RETRACTION SLING GENESEE UNIVERSAL "Y" CONNECTOR NeoForm Annuloplasty Ring Myocardial Temperature Probe TransForm McCarthy Mitral Annuloplasty Ring Sizers TransForm McCarthy Mitral Annuloplasty Ring WellsForm Tricuspid Annuloplasty Band TruForm Sievers Annuloplasty Ring Intra-Art Coronary Artery Retraction Clip, 3mm or 5mm Anastomark Coronary Graft Marker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DNP	Thin Layer Chromatography, Ethosuximide	Clinical Toxicology	Class 2	862.3380	2022-07-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1995-04-19
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2000-04-18
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2019-05-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-21
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	2024-12-20
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2024-12-20
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	2023-09-26
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2023-09-26
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2022-07-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2017-01-12
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2007-12-21

Official Correspondent

James Cross

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GENESEE BIOMEDICAL, INC.

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
K253232	ABBOTT MEDICAL	Seguin Annuloplasty Ring	2025-10-29
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0036-2026	W L Gore & Associates, Inc.	2	GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1723241. Last updated year: 2026. Please use registration number 1723241 when referencing this establishment in official correspondence.