Schoelly Fiberoptic, GmbH
DENZLINGEN Baden-Wurttemberg, DE
SCHOELLY FIBEROPTIC, GMBH appears in FDA device records in DENZLINGEN Baden-Wurttemberg, DE. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Schoelly Fiberoptic, GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Scholly Fiberoptic GmbH510(k), enforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Schoelly Fiberoptic, GmbH between 1999 and 2024. The busiest year on record is 2014, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 3 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | GCJ | Substantially Equivalent | |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | GCJ | Substantially Equivalent | |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | HET | Substantially Equivalent | |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | Substantially Equivalent | |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | FGA | Substantially Equivalent | |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | Substantially Equivalent | |
| K143673 | CMOS Video Nasopharyngoscope System | EOB | Substantially Equivalent | |
| K142249 | SCHOELLY SINUSCOPE | EOB | Substantially Equivalent | |
| K141366 | VIDEO BRONCHOSCOPE SYSTEM | EOQ | Substantially Equivalent | |
| K143221 | Schoelly Laparoscope | GCJ | Substantially Equivalent | |
| K133682 | SCHOELLY ARTHROSCOPE | HRX | Substantially Equivalent | |
| K132009 | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM | EOB | Substantially Equivalent | |
| K992362 | FLEXISCOPE IQ 101 | FET | Substantially Equivalent | |
| K984641 | FLEXISCOPE OPTOMODUL | EIA | Substantially Equivalent | |
| K984556 | SCICAN CLASSIC | EIA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043903 | 3002808088 | SCHOELLY FIBEROPTIC, GMBH | ROBERT-BOSCH-STR. 1-3, DENZLINGEN Baden-Wurttemberg 79211 DE | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- HRXArthroscope
- EOQBronchoscope (Flexible Or Rigid)
- FWFCamera, Television, Endoscopic, Without Audio
- OWNConfocal Optical Imaging
- FAJCystoscope And Accessories, Flexible/Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- HIHHysteroscope (And Accessories)
- FGAKit, Nephroscope
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CCWLaryngoscope, Rigid
- NTNLed Light Source
- FCWLight Source, Fiberoptic, Routine
- EOBNasopharyngoscope (Flexible Or Rigid)
- FECObturator, For Endoscope
- EQHSource, Carrier, Fiberoptic Light
- NAYSystem, Surgical, Computer Controlled Instrument
- IZISystem, X-Ray, Angiographic
- EIAUnit, Operative Dental
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2364-2023 | UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO | There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain