510(k) K232919

Ambu® aScope Gastro Large; Ambu® aBox 2 by Ambu A/S — Product Code FDS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 5, 2024
Date Received: September 19, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

To examine or perform procedures in the stomach. 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)
K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers (October 16, 2024)
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)
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 FDS

K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (February 17, 2026)
K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; (February 6, 2026)
K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Vid (December 16, 2025)
K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (October 31, 2025)
K251708 — EvoEndo Single-Use Endoscopy System (October 10, 2025)
K243388 — Disposable Distal Cap (June 27, 2025)
K250900 — EvoEndo Single-Use Endoscopy System (June 16, 2025)
K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM End (June 10, 2025)
K242635 — Endoscopic Distal Attachment (AF-D series) (May 30, 2025)
K250296 — Disposable Distal Attachment D-201 Series (May 1, 2025)