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510(k) K240849

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 by Ambu A/S — Product Code FAJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 16, 2024
Date Received: March 27, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cystoscope And Accessories, Flexible/Rigid
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To examine and perform 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 clearances by Ambu A/S

K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers (June 11, 2025)
K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers (October 10, 2024)
K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse (August 16, 2024)
K233630 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse (June 24, 2024)
K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2 (April 16, 2024)
K232919 — Ambu® aScope Gastro Large; Ambu® aBox 2 (April 5, 2024)
K233671 — Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 (January 4, 2024)
K232582 — Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (September 20, 2023)
K230332 — Ambu® aScope Colon; Ambu® aBox 2 (September 15, 2023)
K230428 — Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 (August 10, 2023)

Other clearances for product code FAJ

K253226 — UV5000W Handle (October 23, 2025)
K251140 — Zenflow Spring Scope (September 23, 2025)
K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
K250797 — UV5000 Handle (September 11, 2025)
K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)
K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)
K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- (August 1, 2025)
K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers (June 11, 2025)
K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G (December 18, 2024)
K243196 — Uro-G HD Cystoscope (1520) (December 13, 2024)