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Panels › Ear, Nose, Throat › Product code KTI · Class 2

Bronchoscope Accessory

Regulation 874.4680

4510(k)s in 12 months (34 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in KTI

Company510(k)sRecalls
Acclarent, Inc.28
Olympus Surgical Technologies America40
Boston Scientific Corp30
Olympus Medical Systems Corp.30
Bryan Medical, Inc.11
Merit Medical Systems, Inc.20
Serpex Medical, Inc.20
Alton (Shanghai) Medical Instruments Co., Ltd.10
American Endoscopy, Inc.10
Asthmatx, Inc.10
DateFirm and productCodeLinked 510(k)
Sep 5, 2025Olympus Corporation of the Americas
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The she
Open, Classified		 KTIK193517
May 6, 2025Integra LifeSciences Corp. (NeuroSciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Open, Classified		 KTIK110218
Jul 17, 2023Bryan Medical Inc
Aeris Balloon Dilation Catheter
Open, Classified		 KTIK150951
Oct 17, 2018Richard Wolf GmbH
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of path
Open, Classified		 KTINone listed
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Aug 1, 2013Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Terminated		 KTIK090660
K110218
Mar 1, 2012Acclarent, Inc.
Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway tree.
Terminated		 KTIK110218

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