Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007960282

FEI Number

3007960282

Entity Name

Olympus Medical Products Czech

City/State/Country

Prerov II Predmosti, CZ

Establishment Address

Ul Telickova 457/29, Prerov II Predmosti 75124, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030194

PMA Number

N/A

All Registered Proprietary Names

Resection Electrodes with HF cable HF Resection Electrodes HF Resection Electrode Loop with Runner Electrosurgical loops Cysto-urethroscopes and forceps WB990310; WB990311; WB990210;WB990211

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2023-11-07
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2023-11-07
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-11-07
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2023-11-07
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2023-11-07
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-11-07
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2023-11-07
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2023-11-07
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-11-07
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-24
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

OLYMPUS 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
3004450998	Gyrus ACMI, Inc.	Redmond, WA, US
3007389669	Algram Group Ltd	Plymouth Devon, GB
9611174	KEYMED (Medical & Industrial Equipment) Ltd	SOUTHEND-ON-SEA Essex, GB
3010590422	QUEST MEDICAL IMAGING	Wieringerwerf Noord-Holland, NL
3031983124	ODIN MEDICAL LIMITED	London London, City of, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K961841	C.R. Bard, Inc.	BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)	1996-10-09
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
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

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

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3004784537	STERIS AST CZ s.r.o.	VELKA BITES Vysocina, CZ
3028977843	AULEA MEDICAL, INC.	Pleasanton, CA, US
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
1319639	Sterigenics U.S., LLC	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007960282. Last updated year: 2026. Please use registration number 3007960282 when referencing this establishment in official correspondence.