Ambu aScope RLS Slim
FDA 510(k) K181286 · Ambu A/S
510(k) numberK181286
Submission
- Device name
- Ambu aScope RLS Slim
- Applicant
- Ambu A/S
Ballerup, DK - Received
- May 16, 2018
- Decision date
- November 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
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).
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| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 10/16/2024SE |
| K240848 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse…FAJ · Traditional | 10/10/2024SE |
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| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse…FGB · Traditional | 06/24/2024SE |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2FDT · Traditional | 04/16/2024SE |
| K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2FDS · Traditional | 04/05/2024SE |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 AdvanceEOQ · Special | 01/04/2024SE |
Questions and answers
When was Ambu aScope RLS Slim cleared by the FDA?
Ambu aScope RLS Slim (K181286) received a 510(k) decision of Substantially Equivalent on November 30, 2018, 198 days after the submission was received.
What is the product code of K181286?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.