Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222997

FEI Number

1000120548

Entity Name

HENKE SASS WOLF OF AMERICA, INC.

City/State/Country

DUDLEY, MA, US

Establishment Address

135 Schofield Ave, DUDLEY, MA 01571, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HENKE-SASS WOLF, GMBH. (Owner Number: 8010418)

Owner / Operator Contact Address

Keltenstrasse 1, --, TUTTLINGEN, DE-BW D-78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Laparoscope, general and plastic surgery XION Laparoscopes HSW Laparosopes & Accessories XION Otoscope HSW Arthroscope Nasopharyngoscope (flexible / rigid) Henke Sass Wolf of America Arthroscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-04-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	1998-07-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-04-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HENKE-SASS WOLF, 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
9515015	XION GmbH	Berlin, DE
8010418	HENKE-SASS WOLF, GMBH.	TUTTLINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222997. Last updated year: 2026. Please use registration number 1222997 when referencing this establishment in official correspondence.