Bronchoscope Accessory
FDA product code KTI · 32 cleared devices
Class 2
Ear, Nose, Throat
- Regulation
- 21 CFR 874.4680
- Review panel
- EN
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1978-08-14 – 2026-07-24
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).
KTI
2026-07-24
KTI
2026-04-16
ClearTip TBNA Type
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KTI
2026-03-12
LungFlow Basket Catheter
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KTI
2025-12-19
LIA-1 Catheter (542-1)
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KTI
2025-10-08
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
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KTI
2025-07-29
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
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KTI
2025-03-31
Disposable Grasping Forceps FG-52D/FG-54D
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KTI
2025-03-04
Disposable Cytology Brush (AF series)
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KTI
2023-11-15
METIC™- Airway Balloon Catheter
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KTI
2023-09-25
EndoCore
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KTI
2023-05-11
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
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KTI
2023-03-01
Multistage Balloon Dilatation Catheter
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KTI
2022-08-25
Compass Steerable Needle
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KTI
2022-07-20
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
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KTI
2022-03-08
Elation Pulmonary Balloon Dilation Catheter
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KTI
2021-11-24
Trachealator
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KTI
2020-03-18
ViziShot 2 FLEX
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KTI
2019-12-10
Single Use Aspiration Needle
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KTI
2018-07-03
PeriView FLEX
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KTI
2017-09-21
PeriView FLEX
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KTI
2017-06-23
CRE Pulmonary Balloon Dilatation Catheter
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KTI
2017-04-06
ViziShot 2 FLEX
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KTI
2016-09-01
Elation Pulmonary Balloon Dilation
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KTI
2016-07-27
Dillard Airway Dilatation System
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KTI
2016-02-19
ViziShot FLEX
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KTI
2011-03-31
INSPIRA AIR BALLOON DILATION SYSTEM
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KTI
2009-06-12
AIRWAY BALLOON CATHETER INFLATION DEVICE
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KTI
2008-10-20
Y-ADAPTER
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KTI
2002-11-18
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
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KTI
2002-04-05
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
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KTI
1984-04-25
ENDO BITE BLOCK
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KTI
1978-08-14
SPARTA BRONCHIAL BRUSH
View details →No matching devices.
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