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Data / Medical devices / Germany / Henke-Sass Wolf, GMBH.

Henke-Sass Wolf, GMBH.: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 10 510(k) clearances

Henke-Sass Wolf, GMBH. is registered with the FDA (registration 8010418) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 35 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 8, 2018. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Henke-Sass Wolf, GMBH.
FDA registration number
8010418
FEI number
3007130719
Address
Keltenstrasse 1, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator
HENKE-SASS WOLF, GMBH. (8010418)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
June 11, 1986
Registered through
2026
Brand names listed
1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT, 1.9MM X 30º C-MOUNT, A/C, 10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM, 10MM 0° AUTOCLAVABLE LAPAROSCOPE, 10MM 0° BARIATRIC LAPAROSCOPE, AC, 10MM 0° LAPAROSCOPE, AC, 10MM 0° OPERATIVE LAPAROSCOPE WITH 45° EYEPIECE, 10MM 30° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Catheter, G-UKNY2Contract manufactureraccessdata.fda.gov
Adaptor, Holder, SyringeIQG1Contract manufacturer, Manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufacturer, Manufactureraccessdata.fda.gov
Camera, Cine, Endoscopic, Without AudioFWL1Contract manufacturer, Manufactureraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Specification developeraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Contract manufactureraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract manufacturer, Manufactureraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Endoscope, NeurologicalGWG2Contract manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Contract manufactureraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Contract manufactureraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Contract manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufactureraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Contract manufacturer, Manufactureraccessdata.fda.gov
Irrigator, Powered NasalKMA1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufacturer, Manufactureraccessdata.fda.gov
Lithotriptor, Biliary MechanicalLQC2Contract manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Specification developeraccessdata.fda.gov
Nephroscope SetPPE2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
OtoscopeERA1Contract manufacturer, Manufactureraccessdata.fda.gov
ResectoscopeFJL2Contract manufactureraccessdata.fda.gov
Resectoscope, Working ElementFDC2Contract manufactureraccessdata.fda.gov
Syringe, EntKCP1Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Contract manufacturer, Exporter to the USaccessdata.fda.gov
UrethrotomeEZO2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 8, 2018K173070HSW Resection InstrumentsHIHSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
December 7, 2017K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathFAJSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
September 12, 2012K121112STRYKER VIDEO URETEROSCOPEFGBSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
April 1, 2003K030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEEOBSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
October 30, 1998K983067FINE-JECTFMISubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
August 13, 1998K981751SINUSCOPE AND ACCESSORIESEOBSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
January 17, 1997K962075HSW GMBH ARTHROSCOPEHRXSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
February 6, 1996K952186HSW GMBH HYSTEROSCOPES & ACCESSORIESHIHSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
May 16, 1994K941541HSV LAPAROSCOPY SETGCJSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
May 28, 1982K821537HENKE DISPOSABLE SYRINGEFMFSubstantially EquivalentC. B. Dumont Company, Inc.accessdata.fda.gov

Compare with other makers

Updated June 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.