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EOQClass II

Bronchoscope (Flexible Or Rigid)

21 CFR 874.4680 / Ear, Nose, Throat

EOQ is the FDA product code for Bronchoscope (Flexible Or Rigid), a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be...". As of , FDA records hold 241 510(k) clearances under this code, the most recent dated , and 160 recalls.

Classification record

Product code
EOQ
Device name
Bronchoscope (Flexible Or Rigid)
FDA definition
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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
244
Ingested recalls
160

Clearances, product code EOQ

By decision year
244 clearances under product code EOQ with a decision year between 1976 and 2026, 2025 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code EOQ by decision year
YearClearances
19761
19771
19792
19813
19824
19834
19841
19851
19862
19872
19892
19903
19915
19925
19934
199410
199513
199615
19971
19987
19992
20001
20014
20023
20035
20042
20052
20062
20072
20082
20093
20122
20134
20143
20156
20163
20174
20187
201911
202010
202115
202211
202312
202413
202520
20269

Applicants with the most clearances

Product code EOQ

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 157 companies shown, in name order