Richard Wolf GmbH
KNITTLINGEN Baden-Wurttemberg, DE
RICHARD WOLF GMBH appears in FDA device records in KNITTLINGEN Baden-Wurttemberg, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 10 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 1 510(k) clearance for Richard Wolf GmbH in 1996.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611102 | 3002808001 | RICHARD WOLF GMBH | PFORZHEIMER STR. 32, KNITTLINGEN Baden-Wurttemberg 75438 DE | 2026 | and 157 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- FAXBougie, Urological
- EOQBronchoscope (Flexible Or Rigid)
- FCYBulb, Inflation, For Endoscope
- FXMCamera, Still, Endoscopic
- FWGCamera, Television, Endoscopic, With Audio
- FWFCamera, Television, Endoscopic, Without Audio
- FWCCamera, Television, Surgical, With Audio
- FBMCannula And Trocar, Suprapubic, Non-Disposable
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FHAClamp, Penile
- FZQClip, Removable (Skin)
- FMHContainer, Specimen, Sterile
- FZSCurette, Surgical, General Use
- EXQCystometer, Electrical Recording
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- FFLDislodger, Stone, Basket, Ureteral, Metal
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- FASElectrode, Electrosurgical, Active, Urological
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- BWBForceps, Tube Introduction
- FZYHammer, Surgical
- FCTHeadlight, Fiberoptic Focusing
- FHQHolder, Needle, Gastroenterologic
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- FGAKit, Nephroscope
- FDELaparoscopy Kit
- CCWLaryngoscope, Rigid
- EQLLaryngostroboscope
- FXQLens, Camera, Surgical
- FCWLight Source, Fiberoptic, Routine
- FFKLithotriptor, Electro-Hydraulic
- FEOLithotriptor, Ultrasonic
- EWYMediastinoscope, Surgical
- EPTMicroscope, Surgical
- DRIMonitor, Line Isolation
- EOBNasopharyngoscope (Flexible Or Rigid)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- FHRNeedle, Gastro-Urology
- FECObturator, For Endoscope
- FGMProbe And Director, Gastro-Urology
- FJLResectoscope
- FDCResectoscope, Working Element
- EIGRetractor, All Types
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- FXFSpeculum, Illuminated
- BWNTable And Attachments, Operating-Room
- FBPTelescope, Rigid, Endoscopic
- FSMTray, Surgical, Instrument
- FBQTrocar, Gastro-Urology
- FCZTube, Smoke Removal, Endoscopic
- FGBUreteroscope And Accessories, Flexible/Rigid
- EZOUrethrotome
- EXYUroflowmeter
- CAMYoke Assembly, Medical Gas
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1753-2025 | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager). | The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs. | Class II | Open, Classified | |
| Z-1425-2023 | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. | Class II | Open, Classified | |
| Z-1424-2023 | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. | Class II | Open, Classified | |
| Z-1423-2023 | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. | Class II | Open, Classified | |
| Z-1422-2023 | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. | Class II | Open, Classified | |
| Z-2246-2021 | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 | Product labeled as Cutting Electrode may contain BIVAP electrode. | Class II | Terminated | |
| Z-2706-2020 | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged. | Tube material of a smaller diameter was used. | Class II | Terminated | |
| Z-0804-2019 | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation. | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen. | Class II | Open, Classified | |
| Z-1868-2018 | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery. | Tube ends may be mixed up. | Class II | Terminated | |
| Z-2897-2018 | Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. | Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain