Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010153

FEI Number

3006125657

Entity Name

BERCHTOLD GMBH & CO. KG

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

LUDWIGSTALER STR. 25, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Chromophare Surgical Light System ACCEND Spring Arm, Classic, stop 12-21kg ACCEND DROP TUBE HARDWARE KIT ACCEND Suspension, L/FP, 1300/1200mm ACCEND Lighthead Electronics Repair ACCEND Ceiling Cover Hardware ACCEND Drop Tube, 350mm ACCEND Rotating Soffit Assembly ACCEND Suspension, L/L, 1300/1200mm ACCEND Drop Tube, 150 mm, M12 ACCEND Suspension Covers/Caps ACCEND Drop Tube, 400 mm, M12 ACCEND Ceiling Cover ACCEND SPRING ARM PACKAGING KIT ACCEND Light Classic, 1050mm ACCEND L/FP Classic, 1050/925mm ACCEND Spring Arm Hardware ACCEND Drop Tube, 150mm ACCEND FP/L/L Flat, 1400/1300/1200mm ACCEND Conduit Termination Plate ACCEND L/FP Flat, 1300/1200mm ACCEND Suspension, L/L, 1050/925mm ACCEND Suspension, L/FP, 1050/925mm ACCEND Flat Panel Hardware ACCEND Suspension, FP/L/L, 1200/1050/925mm ACCEND LIGHT HEAD PACKAGING KIT ACCEND Suspension, Light, 1050mm ACCEND FP/L/L Classic, 1200/1050/925mm ACCEND Spring Arm, Flat, no stop 12-21kg ACCEND Flat Panel Covers/Caps ACCEND L/FP Flat, 1050/925mm ACCEND Handle Adapter, Devon SlipOn ACCEND Handle Adapter, Sterilizable ACCEND Spring Arm Covers/Caps ACCEND Flat Panel Mount ACCEND Lighthead with Classic Cardanic ACCEND Power Supply ACCEND Spring Arm, Classic, no stop 12-21kg ACCEND L/L Flat, 1300/1200mm ACCEND Cardanic Control Repair ACCEND Handle Cover, Sterilizable ACCEND Cardanic Caps ACCEND Drop Tube, 250 mm, M12 ACCEND Suspension Hardware ACCEND LONG SUSPENSION PACKAGING KIT ACCEND Suspension, FP/L/L, 1400/1300/1200mm ACCEND Lighthead with Flat Cardanic ACCEND Handle Adapter, Devon ScrewOn ACCEND Drop Tube, 400mm ACCEND SUSPENSION PACKAGING KIT ACCEND L/L Classic, 1050/925mm ACCEND Light Flat, 1050mm Surgical Table and Accessory Pads Visum 300 Exam Light Visum XBlade LED Exam Light CHROMOPHARE Examination Light FD 6103 Sirca/ 32 FP CE 3863075 Sirca Ceiling, Double Arm CG 3913275 Sirca Wall, Double, Hardware CF 3893075 Sirca Mobile US FD 6203 Sirca/ UDM CE 3853075 Sirca Ceiling, Single Arm CG 3913175 Sirca Wall Double Outlet Plug FS 6000 Sirca TC Double Arm OPERON Accessories K-TEK CURVE SPINE FRAME K-TEK CLAMSHELL ARMBOARD PAD 3" K-TEK LATERAL POSITIONER, ROUND K-TEK SWIVEL ARMBOARD, SMALL K-TEK CURVE CRANK HANDLE K-TEK LATERAL POSITIONER, RECTANGLE K-TEK SWIVEL ARMBOARD, LARGE K-TEK COMFORT STANDARD ARMBOARD PAD, 2 3/8 K-TEK ARMBOARD, US Strykecam 2 In-Light Camera Strykecam HD In-Light Camera CHROMOVISION HD Cameras Strykecam HD for F-Gen Strykecam for F-Gen Strykecam for Visum LED P59109 StrykeCam 4K, In-Light Camera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2014-12-18
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2016-04-07
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2006-01-18
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2014-12-18
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2010-06-08

Official Correspondent

No official correspondent registered.

US Agent Details

April Malmborg Business: STRYKER ENDOSCOPY Email: april.malmborg@stryker.com Phone: (408) 4093115

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010153. Last updated year: 2026. Please use registration number 8010153 when referencing this establishment in official correspondence.