Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
FDA 510(k) K232582 · Ambu A/S
510(k) numberK232582
Submission
- Device name
- Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- Applicant
- Ambu A/S
Ballerup, DK - Received
- August 25, 2023
- Decision date
- September 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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Questions and answers
When was Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set cleared by the FDA?
Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K232582) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 26 days after the submission was received.
What is the product code of K232582?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.