510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KTRClass II

Tube, Aspirating, Bronchoscope, Rigid

21 CFR 874.4680 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KTR is the FDA product code for Tube, Aspirating, Bronchoscope, Rigid, a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "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)". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KTR
Device name
Tube, Aspirating, Bronchoscope, Rigid
FDA 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).
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code KTR

By decision year
4 clearances under product code KTR with a decision year between 1979 and 1993, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KTR by decision year
YearClearances
19791
19822
19931

Applicants with the most clearances

Product code KTR
Applicants holding the most 510(k) clearances under product code KTR
ApplicantClearances
Sherwood Medical Co.2
Ballard Medical Products1
Kelleher Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code