Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1321175

FEI Number

3001611427

Entity Name

BATES INDUSTRIES

City/State/Country

S Glens Falls, NY, US

Establishment Address

22 Hudson Falls Road, Ste 9, S Glens Falls, NY 12803, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Molded Devices, Inc. (Owner Number: 10058611)

Owner / Operator Contact Address

740 W Knox Road, Tempe, AZ 85284, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZUI ZUI 4 ZSI Uterine Injector Uterine Manipulator/Injector with spring ZUMI Zinnanti Uterine Manipulator Injector 4.5mm Uterine Manipulator Injector 4mm ZUI Tongueometer Uterine Injector 4mm Harris Uterine Injector Harris-Kronner Uterine Manipulator Injector Harris Uterine Manipulator Injector HUI Uterine Manipulator & Injector HUMI Kronner Manipujector Kronner Manipujector Uterine Manipulator Injector Infrared Coagulator IRC Tip/Sheath Redfield IRC Tip/Sheath Sterilized

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2022-12-20
IKE	Transducer, Miniature Pressure	Physical Medicine	Class 1	890.1615	2022-12-20
HES	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)	Obstetrics/Gynecology	Class 2	884.1300	2022-12-20
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2022-12-20
HES	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)	Obstetrics/Gynecology	Class 2	884.1300	2022-12-20
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2022-12-20

Official Correspondent

Samuel Brayton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Molded Devices, 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
1223009	MDI East, Inc., dba Medefab	JAFFREY, NH, US
3006686250	Guangzhou Schauenburg-Truplast Hose Technology Ltd.	Guangzhou Guangdong, CN
3015146495	MOLDED DEVICES, INC.	Tempe, AZ, US
8022265	GLOBALMED, INC.	TRENTON Ontario, CA
3011324393	MEDICAL MURRAY, INC.	Charlotte, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17

Similar Registrations

Registration Number	Establishment Name	Location
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
3010131137	BIOTRONIX HEALTHCARE INDUSTRIES INC.	Orlando, FL, US
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1321175. Last updated year: 2026. Please use registration number 1321175 when referencing this establishment in official correspondence.