Home › Device types › KTI
Bronchoscope Accessory
FDA product code KTI · Class 2 · Ear, Nose, Throat
180
Registered devices
1,011
Adverse events
12
Recalls
34
510(k) clearances
Devices with this code
INSPIRA AIR — ACCLARENT, INC.Elation™ — Merit Medical Systems, Inc.NA — Richard Wolf GmbHTrachealator Non-occlusive Airway Dilation Balloon — DISA MEDINOTEC (PTY) LTDMultiStage® — Dongguan TT Medical, Inc.NA — Richard Wolf GmbHTrachealator — DISA MEDINOTEC (PTY) LTDNA — Richard Wolf GmbHNA — Richard Wolf GmbHElation™ — Merit Medical Systems, Inc.Elation™ — Merit Medical Systems, Inc.NA — Richard Wolf GmbHTEXAS — Richard Wolf GmbHTrident(TM) Endobronchial Ultrasound Biopsy Needle — Micro-Tech (Nanjing) Co., Ltd.Trident(TM) Endobronchial Ultrasound Biopsy Needle — Micro-Tech (Nanjing) Co., Ltd.Elation™ — Merit Medical Systems, Inc.INSPIRA AIR — ACCLARENT, INC.TEXAS — Richard Wolf GmbHElation™ — Merit Medical Systems, Inc.ViziShot 2 FLEX — Gyrus ACMI, LLCTrident(TM) Endobronchial Ultrasound Biopsy Needle — Micro-Tech (Nanjing) Co., Ltd.MultiStage® — Dongguan TT Medical, Inc.DISPOSABLE GRASPING FORCEPS — OLYMPUS MEDICAL SYSTEMS CORP.NA — Richard Wolf GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-06 | Olympus Corporation of the Americas | Potential for undetected, deformed a-traumatic tips. |
| 2025-04-04 | Integra LifeSciences Corp. (NeuroSciences) | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. |
| 2023-05-16 | Bryan Medical Inc | Devices were mislabeled. |
| 2018-10-17 | Richard Wolf GmbH | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructiona |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructiona |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructiona |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructiona |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructiona |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructiona |
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