Tube, Aspirating, Bronchoscope, Rigid
The Rigid Bronchoscope Aspirating Tube is a tubular accessory used with a rigid bronchoscope to suction secretions, blood, or foreign material from the airways during bronchoscopic procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KTR, regulated under 21 CFR 874.4680, in the Ear, Nose, Throat medical specialty. Where the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission, per FDA guidance (82 FR 26807).
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Basic Information
- Product Code
- KTR
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K923487 | BAL CATH | Jul 30, 1993 | Unknown | Ballard Medical Products |
| K822255 | RIGID SUCTION TIPS | Aug 25, 1982 | Substantially Equivalent | Kelleher Corp. |
| K820572 | ARGYLE DELEE SUCTION CATHETER W/MUCOUS | Apr 09, 1982 | Substantially Equivalent | Sherwood Medical Co. |
| K791327 | ARGYLE TAUSSIG CULTURE CATHETER | Aug 22, 1979 | Substantially Equivalent | Sherwood Medical Co. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.