Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment
FDA 510(k) K033225 · Olympus Optical Co., Ltd.
Submission
- Device name
- Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment
- Applicant
- Olympus Optical Co., Ltd.
Melville, NY, US - Received
- October 6, 2003
- Decision date
- October 16, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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| 510(k) | Device | Decision |
|---|---|---|
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| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
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| K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesEOQ · Traditional | 01/31/2003SE |
Questions and answers
When was Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment cleared by the FDA?
Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment (K033225) received a 510(k) decision of Substantially Equivalent on October 16, 2003, 10 days after the submission was received.
What is the product code of K033225?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.