Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183446

FEI Number

2183446

Entity Name

DIVERSATEK HEALTHCARE INC

City/State/Country

Milwaukee, WI, US

Establishment Address

102 EAST KEEFE AVE., Milwaukee, WI 53212, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

DIVERSATEK HEALTHCARE INC (Owner Number: 2183446)

Owner / Operator Contact Address

102 EAST KEEFE AVE., --, Milwaukee, WI 53212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K972119

PMA Number

N/A

All Registered Proprietary Names

Cleanflow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2020-12-14
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2020-12-14
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2018-06-27
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2023-12-20
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-12-20
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2010-07-23
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2018-07-13
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2018-07-13
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2020-12-14
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2017-10-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-23
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2012-09-05
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2018-11-07
CBC	Bottle, Collection And Trap, Breathing System (Uncalibrated)	General Hospital	Class 2	880.6740	2022-02-18
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2010-07-23
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2025-11-19
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2012-02-21
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2023-12-20
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-12-20
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2020-10-07
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2019-08-01
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2019-08-01
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-12-05
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2022-12-05
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2015-03-12
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2018-11-07
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-06-27
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-11-21
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2010-12-10
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2022-06-22
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2025-11-21
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	1994-08-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIVERSATEK HEALTHCARE 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
3009106214	Diversatek Vietnam Company Limited	Thuan An City Binh Duong, VN

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-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
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-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132

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3003790304	GYRUS ACMI, INC.	Westborough, MA, US
3010288205	Hangzhou AGS MedTech Co., Ltd.	Hangzhou Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183446. Last updated year: 2026. Please use registration number 2183446 when referencing this establishment in official correspondence.