Ovesco Endoscopy USA

FDA Device Registration & Listing · Cary, NC, US · Registration 3008720584

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008720584
FEI Number
3008720584
Entity Name
Ovesco Endoscopy USA
City/State/Country
Cary, NC, US
Establishment Address
15300 Weston Parkway, Suite 101, Cary, NC 27513, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Ovesco Endoscopy (Owner Number: 10031680)
Owner / Operator Contact Address
15300 Weston Parkway, Suite 101, Cary, NC 27513, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K141794
PMA Number
N/A

All Registered Proprietary Names

Traction Polypectomy Snare colonic FTRD prOVE Cap gastroduodenal FTRD prOVE Cap OTSC®neo System Set (1001n-14n, 100.27n-31n) remOVE FBR Set FTRD Grasper Set OTSG Xcavator BARS Set (100.60) AWC AWCduo remOVE DC Cutter Set remOVE DC Impulse mini OTSC System Set OTSC System Set OTSC Proctology ArgoCap OTSC Proctology Anchor OTSC Anchor 165 BARS Anchor black OTSC Twin Grasper 165 BARS Anchor silver OTSC Twin Grasper 220 OTSC Anchor 220tt AqaNife Fistula Brush DIMEDA gastroduodenal FTRD Set LiftUp LiftUp Kit Coag Endo-Dissector Coag Dissector

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
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2014-02-18
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2026-02-04
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2010-02-25
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2024-09-03
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-08-01
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 2010-12-17
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2015-09-18
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-06-04
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2022-11-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-11-24
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
PLL Submucosal Injection Agent Gastroenterology, Urology Class 2 876.1500 2022-08-16
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2015-01-14

Official Correspondent

Marc Schurr

US Agent Details

No US Agent registered (Local establishment).

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
3006696607 OVESCO ENDOSCOPY AG Tuebingen Baden-Wurttemberg, DE

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
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

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-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

Similar Registrations

Registration Number Establishment Name Location
3008040402 Olympus Vietnam Co. Ltd. Dong Nai City, VN
3006696607 OVESCO ENDOSCOPY AG Tuebingen Baden-Wurttemberg, DE
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 3008720584. Last updated year: 2026. Please use registration number 3008720584 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.