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Bronchoscope Accessory
FDA product code KTI · Class 2 · Ear, Nose, Throat
171
Registered devices
977
Adverse events
12
Recalls
34
510(k) clearances
Devices with this code
andorate® Biopsy Valve — GA Health Company LimitedNA — Richard Wolf GmbHPILLING — TELEFLEX INCORPORATEDSingle Use Aspiration Needle NA-201SX-4021 — OLYMPUS MEDICAL SYSTEMS CORP.Compass Steerable Needle — SERPEX MEDICAL INC.CRE Pulmonary — BOSTON SCIENTIFIC CORPORATIONCONMED — Conmed CorporationElation™ — Merit Medical Systems, Inc.PILLING — TELEFLEX INCORPORATEDMonarch Pouch FR — PRAXIS MEDICAL LLCAreus(TM) Endobronchial Ultrasound Aspiration Needle — Micro-Tech (Nanjing) Co., Ltd.NA — Richard Wolf GmbHViziShot 2 FLEX — Gyrus ACMI, LLCNA — Richard Wolf GmbHAdapter SRA-2-01 — SERPEX MEDICAL INC.INSPIRA AIR — ACCLARENT, INC.Single Use Aspiration Needle — OLYMPUS MEDICAL SYSTEMS CORP.TEXAS — Richard Wolf GmbHMultiStage® — Dongguan TT Medical, Inc.EndoCore — PRAXIS MEDICAL LLCDISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3Fr.) — OLYMPUS MEDICAL SYSTEMS CORP.MultiStage® — Dongguan TT Medical, Inc.NA — Richard Wolf GmbHNA — 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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