FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Ambu aScope RLS Slim
K Number: K181286
·
Decision Nov 30, 2018
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
38
Review Days
198
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Basic Information
- Device Name
- Ambu aScope RLS Slim
- K Number
- K181286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu A/S
- Date Received
- May 16, 2018
- Decision Date
- November 30, 2018
- Product Code
- EOB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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|---|---|---|---|
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| K250269 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) | Jun 11, 2025 | Substantially Equivalent |
| K240849 | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 | Oct 16, 2024 | Substantially Equivalent |
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| K242108 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance | Aug 16, 2024 | Substantially Equivalent |
| K233630 | Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 | Jun 24, 2024 | Substantially Equivalent |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2 | Apr 16, 2024 | Substantially Equivalent |
| K232919 | Ambu® aScope Gastro Large; Ambu® aBox 2 | Apr 5, 2024 | Substantially Equivalent |
| K233671 | Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Jan 4, 2024 | Substantially Equivalent |
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Sep 20, 2023 | Substantially Equivalent |