Mucus Collection Probe, Models BC-401C & BC-402C
FDA 510(k) K022446 · Aomori Olympus Co., Ltd.
510(k) numberK022446
Submission
- Device name
- Mucus Collection Probe, Models BC-401C & BC-402C
- Applicant
- Aomori Olympus Co., Ltd.
Melville, NY, US - Received
- July 25, 2002
- Decision date
- March 28, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Mucus Collection Probe, Models BC-401C & BC-402C cleared by the FDA?
Mucus Collection Probe, Models BC-401C & BC-402C (K022446) received a 510(k) decision of Substantially Equivalent on March 28, 2003, 246 days after the submission was received.
What is the product code of K022446?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.