Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath
FDA 510(k) K963795 · Vision-Sciences, Inc.
Submission
- Device name
- Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath
- Applicant
- Vision-Sciences, Inc.
Natick, MA, US - Received
- September 23, 1996
- Decision date
- December 23, 1996
- 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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| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…EOX · Special | 08/29/2007SE |
| 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 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath cleared by the FDA?
Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath (K963795) received a 510(k) decision of Substantially Equivalent on December 23, 1996, 91 days after the submission was received.
What is the product code of K963795?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.