Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014644276

FEI Number

3006149253

Entity Name

SCHOELLY-OPTIX OOD

City/State/Country

Panagyurishte Pazardzhik, BG

Establishment Address

Krastyo Geshanov 30, Panagyurishte Pazardzhik 4500, BG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SCHOELLY FIBEROPTIC, GMBH (Owner Number: 9004385)

Owner / Operator Contact Address

ROBERT-BOSCH-STR. 1-3, --, DENZLINGEN, DE-NOTA 79211, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LED Light Sources Arthroscopes Endoscopic Camera Control Unit NIR FI Light Source Endoscopic Camera Heads 2D NIR FI Laparoscopes Uretero-Renoscope Sealing caps Three slot membrane Laparoscopes Hysteroscopes Cystoscopes Light guides

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2015-11-10
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2014-08-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-10-15
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2023-06-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-06-06
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2023-06-06
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-06-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-08-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2013-03-08
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-03-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-03-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2013-03-08
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-09-02
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2016-02-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-02-11
FEC	Obturator, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2016-02-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-01-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-05-24
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-03-12
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2015-03-12
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2011-01-27

Official Correspondent

GERHARD HERBSTRITT

US Agent Details

James Bonneville Business: SCHOELLY USA Inc. Email: j.bonneville@schoelly-usa.com Phone: (508) 9268855

Related Public Records

Same Entity

SCHOELLY FIBEROPTIC, GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043903	SCHOELLY FIBEROPTIC, GMBH	DENZLINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K191144	Mauna Kea Technologies	Cellvizio 100 Series System with Confocal Miniprobes	2020-01-24
K243591	Optosurgical, LLC	OPTOVISION Endoscopic Light Source Unit	2025-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014644276. Last updated year: 2026. Please use registration number 3014644276 when referencing this establishment in official correspondence.