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510(k) K191080

Ambu aScope 4 RhinoLaryngo Slim by Ambu A/S — Product Code EOB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 22, 2019
Date Received: April 24, 2019
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nasopharyngoscope (Flexible Or Rigid)
Device Class: Class II
Regulation Number: 874.4760
Review Panel: EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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)
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)

Other clearances for product code EOB

K241731 — Outlook Surgical Versa One System (8900139) (August 11, 2025)
K243639 — Portare System (FA-001) (June 5, 2025)
K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (March 3, 2025)
K234096 — MonoStereo (September 19, 2024)
K232435 — Rhinolaryngoscope system (April 26, 2024)
K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. (August 3, 2023)
K222587 — PatCom Distal Chip Endoscope (July 28, 2023)
K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (June 14, 2023)
K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (December 28, 2022)
K221581 — Single-Use Flexible Rhinolaryngoscope (November 18, 2022)