# K213334: Monarch Platform, Urology

- Pathway: 510(k) (Traditional)
- Applicant: Auris Health, Inc.
- Decided: Apr 29, 2022 after 205 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931154 (1993). 35 ancestors in all.
No later device cites it as a predicate yet.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153049: LithoVue System, Boston Scientific Corporation (2015) Summary page 5.
- K162992: Karl Storz UROMAT E.A.S.I., Karl Storz Endoscopy America, Inc. (2017) Summary page 5.
- K172527: Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe, Cook Incorporated (2017) Summary page 6.
- K994223: Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20, Richard Wolf Medical Instruments Corp. (2000) Summary page 6.
- K172929: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath, Boston Scientific Corporation (2018) Summary page 6.
- (no number) LithAssist Suction Control for Laser Lithotripsy: named in the summary without a submission number

## Recalls of this device
- Aug 2, 2024 · Class II · Z-0052-2025: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to pro

## Indications for use
The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

Source page: https://510kreport.com/device/K213334
Methodology: https://510kreport.com/methodology