FDA 510(k)

B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM

K-Number: K021344 · 2002-05-24

Decision Date2002-05-24

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vision-Sciences, Inc.. It received FDA 510(k) clearance on 2002-05-24 under 510(k) number K021344. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM?

B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-24. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K021344.

When did B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM receive FDA 510(k) clearance?

B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM received FDA 510(k) clearance on 2002-05-24, under 510(k) number K021344.

Who is the listed applicant for B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM?

The FDA 510(k) record lists Vision-Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM?

The FDA product code for B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM is EOQ.

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Other records listing Vision-Sciences, Inc. as applicant

K102733VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR K100125VISION SCIENCES FLEXIBLE ENT SCOPE K091768VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES K072180VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM K071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM K072073VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR

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Related Devices (Code: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.