Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006696607

FEI Number

3006696607

Entity Name

OVESCO ENDOSCOPY AG

City/State/Country

Tuebingen Baden-Wurttemberg, DE

Establishment Address

Friedrich-Miescher-Strasse 9, Tuebingen Baden-Wurttemberg 72076, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Ovesco Endoscopy (Owner Number: 10031680)

Owner / Operator Contact Address

15300 Weston Parkway, Suite 101, Cary, NC 27513, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242586

PMA Number

N/A

All Registered Proprietary Names

Traction Polypectomy Snare diagnostic FTRD Set colonic FTRD Set FTRD System Set OTSC®neo System Set (1001n-14n, 100.27n-31n) AWC AWCduo Fistula Brush LiftUp LiftUp Kit mini OTSC System Set OTSC System Set Coag Endo-Dissector Coag Dissector remOVE DC Cutter Set remOVE DC Impulse DIMEDA gastroduodenal FTRD Set stentfix OTSC System Set AqaNife colonic FTRD prOVE Cap gastroduodenal FTRD prOVE Cap remOVE FBR Set FTRD Grasper Set OTSG Xcavator ArgoCap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2015-01-14
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2018-11-15
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2018-11-15
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2018-11-15
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-11-15
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2026-02-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-08-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-11-24
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2022-08-16
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2010-12-17
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2015-01-14
QAG	Endoscopic Electrosurgical Clip Cutting System	Obstetrics/Gynecology	Class 2	876.4310	2018-01-11
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2020-06-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-06-04
KBO	Guillotine, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1994-02-18
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-06-04
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2019-10-23
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2019-10-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-03-10
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-02-18
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2010-02-25
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-06-04

Official Correspondent

Marc Schurr

US Agent Details

Geoffrey Yates Business: Ovesco Endoscopy USA Inc. Email: gyates@ovesco-usa.com Phone: (919) 6519449

Related Public Records

Same Entity

Ovesco Endoscopy

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008720584	Ovesco Endoscopy USA	Cary, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K923489	Cox Medical Ent., Inc.	COX DISPOSABLE RETRIEVAL DEVICES	1992-09-23
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-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0015-2023	Hobbs Medical, Inc.	2	Hobbs Medical Polypectomy Snare Catalog Number: 4563
Z-0016-2023	Hobbs Medical, Inc.	2	Hobbs Medical Polypectomy Snare Catalog Number: 4564
Z-0026-2023	Hobbs Medical, Inc.	2	Hobbs Helical Retrieval Basket Catalog Number: 4806
Z-0027-2023	Hobbs Medical, Inc.	2	Hobbs Helical Retrieval Basket Catalog Number: 4808

Similar Registrations

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3008040402	Olympus Vietnam Co. Ltd.	Dong Nai City, VN
3008720584	Ovesco Endoscopy USA	Cary, NC, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL
1037905	Wilson-Cook Medical Inc.	Winston Salem, NC, US
1000121056	Boston Scientific Corporation	Coventry, RI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006696607. Last updated year: 2026. Please use registration number 3006696607 when referencing this establishment in official correspondence.