Henke-Sass Wolf, GmbH.
TUTTLINGEN Baden-Wurttemberg, DE
HENKE-SASS WOLF, GMBH. appears in FDA device records in TUTTLINGEN Baden-Wurttemberg, DE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Henke-Sass Wolf, GmbH. between 1994 and 2018. The busiest year on record is 1994, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1996 | 1 |
| 2010 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173070 | HSW Resection Instruments | HIH | Substantially Equivalent | |
| K171336 | Cystoscope 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 Sheath | FAJ | Substantially Equivalent | |
| K101547 | HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) | FMF | Substantially Equivalent | |
| K952186 | HSW GMBH HYSTEROSCOPES & ACCESSORIES | HIH | Substantially Equivalent | |
| K943624 | ELMED PNEUMOPERITONEUM NEEDLES | FHO | Substantially Equivalent | |
| K941967 | HSW LAPAROSCOPE AND ACCESSORIES | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010418 | 3007130719 | HENKE-SASS WOLF, GMBH. | KELTENSTRASSE 1, TUTTLINGEN Baden-Wurttemberg 78532 DE | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNYAccessories, Catheter, G-U
- IQGAdaptor, Holder, Syringe
- HRXArthroscope
- FWLCamera, Cine, Endoscopic, Without Audio
- KYWContainer, Liquid Medication, Graduated
- FAJCystoscope And Accessories, Flexible/Rigid
- FFLDislodger, Stone, Basket, Ureteral, Metal
- KYXDispenser, Liquid Medication
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWGEndoscope, Neurological
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FFDEvacuator, Bladder, Manually Operated
- KQTEvacuator, Gastro-Urology
- GENForceps, General & Plastic Surgery
- HIHHysteroscope (And Accessories)
- NWWHysteroscope Accessories
- KMAIrrigator, Powered Nasal
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CCWLaryngoscope, Rigid
- LQCLithotriptor, Biliary Mechanical
- EOBNasopharyngoscope (Flexible Or Rigid)
- FMINeedle, Hypodermic, Single Lumen
- PPENephroscope Set
- LXHOrthopedic Manual Surgical Instrument
- ERAOtoscope
- FHOPneumoperitoneum Needle
- FJLResectoscope
- FDCResectoscope, Working Element
- KCPSyringe, Ent
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- FSMTray, Surgical, Instrument
- FGBUreteroscope And Accessories, Flexible/Rigid
- EZOUrethrotome
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain