Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010230734

FEI Number

3010230734

Entity Name

DYNAMIC DIAGNOSTICS INCORPORATED

City/State/Country

Plymouth, MI, US

Establishment Address

800 Junction St, Plymouth, MI 48170, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Dynamic Diagnostics Incorporated (Owner Number: 10044579)

Owner / Operator Contact Address

800 Junction St, Plymouth, MI 48170, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091672

PMA Number

N/A

All Registered Proprietary Names

Endoscopy Kit Post Op Eye Kit Urinalysis Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-13
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-02-19
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2019-03-13
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-03-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-02-27
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2019-03-12
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-02-19
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-02-19
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2019-03-13
ODR	Electrosurgical Patient Return Electrode	General, Plastic Surgery	Class 2	878.4400	2019-03-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-13

Official Correspondent

Trevor Tynan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dynamic Diagnostics Incorporated

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010230734. Last updated year: 2026. Please use registration number 3010230734 when referencing this establishment in official correspondence.