FUNS-10, FUNS-11

FDA 510(k) K862551 · Reichert-Jung, Inc.

Substantially Equivalent

510(k) numberK862551

Submission

Device name
FUNS-10, FUNS-11
Applicant
Reichert-Jung, Inc.
Southbridge, MA, US
Received
July 3, 1986
Decision date
September 12, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K262488Single-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
K261153LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional Boston Scientific Corporation08/26/2026SE
K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special Scivita Medical Technology Co., Ltd.08/14/2026SE
K253505Zamenix™ PFGB · Traditional Roen Surgical, Inc.08/07/2026SE
K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional MacroLux Medical Technology Co., Ltd.07/20/2026SE
K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional Anhui Happiness Workshop Instruments Co., Ltd.04/09/2026SE
K260013CVAC Image ProcessorFGB · Traditional Calyxo, Inc.03/06/2026SE
K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional Zhejiang Geyi Medical Instrument Co., Ltd.12/16/2025SE
K251951Single-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
K253411Miniature Telescope for Urology (27033AA)FGB · Traditional Karl Storz SE & CO. KG11/18/2025SE

More from Karl Storz SE & CO. KG

510(k)DeviceDecision
K864821Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2EOB · Traditional 02/10/1987SE
K852994Reichert Flexible Laryngoscope, Model LS-11CAL · Traditional 07/29/1985SE

Questions and answers

When was FUNS-10, FUNS-11 cleared by the FDA?

FUNS-10, FUNS-11 (K862551) received a 510(k) decision of Substantially Equivalent on September 12, 1986, 71 days after the submission was received.

What is the product code of K862551?

The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.