Model FUS-1, Flexible Ureteroscope
FDA 510(k) K811535 · American Optical Corp.
510(k) numberK811535
Submission
- Device name
- Model FUS-1, Flexible Ureteroscope
- Applicant
- American Optical Corp.
Mchenry, IL, US - Received
- June 1, 1981
- Decision date
- June 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FGB – Ureteroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FGB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 09/09/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | Boston Scientific Corporation | 08/26/2026SE |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | Scivita Medical Technology Co., Ltd. | 08/14/2026SE |
| K253505 | Zamenix PFGB · Traditional | Roen Surgical, Inc. | 08/07/2026SE |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional | MacroLux Medical Technology Co., Ltd. | 07/20/2026SE |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional | Anhui Happiness Workshop Instruments Co., Ltd. | 04/09/2026SE |
| K260013 | CVAC Image ProcessorFGB · Traditional | Calyxo, Inc. | 03/06/2026SE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 12/16/2025SE |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 12/16/2025SE |
| K253411 | Miniature Telescope for Urology (27033AA)FGB · Traditional | Karl Storz SE & CO. KG | 11/18/2025SE |
More from Karl Storz SE & CO. KG
| 510(k) | Device | Decision |
|---|---|---|
| K950881 | Phaco TipHQC · Traditional | 09/06/1995SE |
| K950880 | Aoi Universal Ultrasonic HandpieceHQC · Traditional | 05/26/1995SE |
| K931358 | AORP4000 Reusable PakHQC · Traditional | 02/22/1994SE |
| K931354 | P4000 PhacoemulsifierHQC · Traditional | 02/22/1994SE |
| K931357 | AOD4000 Disposable PakHQC · Traditional | 01/25/1994SE |
| K820790 | Flexible Proctosigmoidoscope, #FPS-3FAM · Traditional | 04/01/1982SE |
| K813430 | Tissue Processing Cassettes & AccessIDL · Traditional | 12/29/1981SE |
| K812965 | Model SC-6, Flexible SiamoidoscopeFAM · Traditional | 11/02/1981SE |
| K812051 | Photolite Aolite Tintomatic LensHQG · Traditional | 09/08/1981SE |
| K812063 | SR-1V Data PrinterHKO · Traditional | 08/18/1981SE |
Questions and answers
When was Model FUS-1, Flexible Ureteroscope cleared by the FDA?
Model FUS-1, Flexible Ureteroscope (K811535) received a 510(k) decision of Substantially Equivalent on June 23, 1981, 22 days after the submission was received.
What is the product code of K811535?
The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.