B-F200 Bronchoscope with BSS-F21 Endosheath System
FDA 510(k) K021344 · Vision-Sciences, Inc.
510(k) numberK021344
Submission
- Device name
- B-F200 Bronchoscope with BSS-F21 Endosheath System
- Applicant
- Vision-Sciences, Inc.
Ayer, MA, US - Received
- April 29, 2002
- Decision date
- May 24, 2002
- 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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| K102733 | Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences…EOB · Traditional | 05/18/2011SE |
| K100125 | Vision Sciences Flexible ENT ScopeEOB · Special | 02/25/2010SE |
| K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, DPU-5000/DPU-5050…EOQ · Traditional | 08/03/2009SE |
| K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemFAJ · Traditional | 12/18/2007SE |
| K071127 | Flexible Hysteroscope with Endosheath SystemHIH · Traditional | 11/16/2007SE |
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| K072073 | Vision-Sciences ENT-5000 and ENT-5100 Video ENT Scope with Endosheath System…EOB · Special | 08/29/2007SE |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne ScopeEOX · Special | 08/02/2007SE |
| K053560 | Modified Endosheath System for Vsi Flexible CystoscopeFAJ · Special | 03/16/2006SE |
| K050972 | Vision-Sciences ENT-3000 ScopeEOB · Special | 04/29/2005SE |
Questions and answers
When was B-F200 Bronchoscope with BSS-F21 Endosheath System cleared by the FDA?
B-F200 Bronchoscope with BSS-F21 Endosheath System (K021344) received a 510(k) decision of Substantially Equivalent on May 24, 2002, 25 days after the submission was received.
What is the product code of K021344?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.