Cleared Special

K021344 - B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM

K021344 is an FDA 510(k) clearance for B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSH..., manufactured by Vision-Sciences, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Special 510(k) pathway after a 25-day FDA review.

K021344 · Vision-Sciences, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
25d
Days
Class 2
Risk

K021344 is an FDA 510(k) clearance for the B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Ayer, US). The FDA issued a Cleared decision on May 24, 2002 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vision-Sciences, Inc. devices

FDA 510(k) Submission Details - K021344

510(k) Number K021344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2002
Decision Date May 24, 2002
Days to Decision 25 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 90d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition 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 Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 207
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K021344.
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K033225 · Olympus Optical Co., Ltd. · Oct 2003
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
K023984 · The Olympus Optical Co. · Jan 2003
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · Pentax Precision Instrument Corp. · Oct 2002
OLYMPUS SPRAY CATHETER PW-6C-1
K012073 · The Olympus Optical Co. · Aug 2001
COAGULATION ELECTRODE, MODEL 2000
K993900 · Broncus Technologies, Inc. · Jan 2000
PILLING WECK SURGICAL Y STENT FORCEPS
K990547 · Pilling Weck, Inc. · Apr 1999