Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1651395

FEI Number

3003012447

Entity Name

Medivators Inc

City/State/Country

Conroe, TX, US

Establishment Address

3150 Pollok Drive, Conroe, TX 77303, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STERIS Corporation (Owner Number: 2150060)

Owner / Operator Contact Address

5960 Heisley Rd, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232067

PMA Number

N/A

All Registered Proprietary Names

Medline Sterile Disposable Surgical Gowns DEFENDO Valve and Connector Kit (100310, 100312, 100315) DEFENDO Air/Water and Suction Valves (100305, 100306, 100311) DEFENDO Air/Water/Suction and Biopsy Valves and Kits (1003xx) Endo Smartcap UCR Adaptor ENDOGATOR Tubing for ENDO STRATUS Pump ENDOGATOR Tubing for EGP-100 Irrigation Pump ENDOGATOR Single Use Auxiliary Water Jet Connector for Pentax Endoscopes (100242) ENDOGATOR Channel Adapter (100136) ENDOGATOR Single Use Auxiliary Water Jet Connectors for Olympus Endoscopes (100241) ENDOGATOR Backflow Valve (100126) ENDOGATOR Tubing for Endostat II/III Unit Intercept Detergent WIPES Intercept Detergent Medline Drawstring Pad Wide (101800) Intercept Plus Detergent Single Ended Brush (100401) (CO-CFE) PULL THRU 4.8MM CASSETTE REFILL (180X12) 4002598 INTERCEPT Bedside Kit MICRO PULL THRU CASSETTE REFILL (360X12) 4002607 DOUBLE BALLOON PULL THRU W/ STUBBY COMBO PULL THRU CASSETTE REFILL (240X12) 4002597 MICRO PULL THRU SINGLE (4002604) MINI PULL THRU CASSETTE REFILL (2400X4) 4002602 DOUBLE ENDED STUBBY BRUSH (180) PULL THRU CHANNEL CLEANING BRUSH SINGLE (4002592) MICRO PULL THRU 60PK W/ CASSETTE, MOUNT (4002605) Intercept Foam PULL THRU CASSETTE WALL MOUNT (4002594) Transport Pad (100800) DOUBLE ENDED STUBBY BRUSH SINGLE PULL THRU W/ STUBBY COMBO SINGLE (4002593) MICRO PULL THRU CASSETTE REFILL (180X12) 4002606 MINI PULL THRU CASSETTE REFILL (360X12) (4002603) MINI PULL THRU W/ STUBBY COMBO (4002600) PULL THRU CASSETTE REFILL PACK (180X12) 4002596 PULL THRU 60PK W/ CASSETTE AND MOUNT (4002601) PULL THRU DEMO UNIT (4002612) DOUBLE BALLOON PULL THRU SINGLE MINI PULL THRU 60PK W/ CASSETTE, MOUNT (4002601) MINI PULL THRU SINGLE (4002599) Intercept One Ready-to-Use Bedside Kit Intercept Next-Generation Detergent Bedside Kit ENDOGATOR Hybrid Irrigation Tubing Scope Buddy Plus Air/Water Blanking Cap (PY-MF) Scope Buddy Plus Endoscope Flushing Aid (PY-MF) Scope Buddy Plus Tubing (CO-MF, PY-SD) Endo Gator Hybrid Tubing Kits EndoStratus Irrigation Pump EGA-500 Endo Smartcap Endoscope Leak Tester Model ZUTR10003 Defendo Fujifilm 700 series valve kits DEFENDO Valve and Connector Kit (100310, 100312, 100315) DEFENDO Air/Water/Suction and Biopsy Valves and Kits (1003xx) DEFENDO Air/Water and Suction Valves (100306) DEFENDO Air/Water and Suction Valves (100305) EndoGator Irrigation Tubing Pediatric Bite Block Adult Bite Block Endogator Irrigation Pump Model EGP-100 DEFENDO Air/Water/Suction and Biopsy Valve (100316) DEFENDO Air/Water and Suction Valves (100317) DEFENDO Valve and Connector Kit (100315) Defendo Valve Kit Via procedure kit ENDOGATOR Kit Endo Carry-On Procedure Kit Defendo Y-Opsy Irrigator (100303) Scope Buddy Endoscope Flushing Aid (PY-CFE) Scope Buddy Plus Endoscope Flushing Aid (PY-MF) Scope Buddy Plus Tubing (CO-MF, PY-SD) Impervious Gown Medline (200352) Impervious Gown Welmed (200350, 200351) Endo Smartcap Defendo Cleaning Adapter Non-Sterile (4008055) EndoStratus CO2 Insufflator EGA-501 Veriscan LT Automated Endoscope Leak Tester (PY-CFE) Endo-Leak Tester Adapters (CO-MF) Endo-Leak Tester (CO-MF) DEFENDO Valve and Connector Kit (100310, 100312, 100315) DEFENDO Air/Water/Suction and Biopsy Valves and Kits (100301, 100305, 100310) Transport Pad Defendo Fujifilm 500/600 Air/Water, Suction, and Biopsy Valve (100313) Defendo Fujifilm 500/600 Air/Water and Suction Valve (100314) Defendo Fujifilm 500/600 Air/Water, Suction, and Biopsy Valve and ENDOGATOR Connector (100312)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-03-26
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2011-10-24
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2011-10-24
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2013-07-09
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-04-12
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-04-18
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-09-13
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-01-22
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2012-10-18
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-03-24
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2024-04-25
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-01-05
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2012-04-18
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-03-11
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2022-04-28
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2026-04-13
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2017-04-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2015-02-05
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-03-15
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2012-10-18
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2008-10-09
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2011-10-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-02-28
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-03-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS 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
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

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

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1527607	SRI Healthcare, LLC	MASON, OH, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1651395. Last updated year: 2026. Please use registration number 1651395 when referencing this establishment in official correspondence.