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

Accessory, Assisted Reproduction, Exempt

21 CFR 884.6120 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PUB is the FDA product code for Accessory, Assisted Reproduction, Exempt, a class II device type, regulated under 21 CFR 884.6120. FDA's definition for this code reads: "This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 6 recalls.

Classification record

Product code
PUB
Device name
Accessory, Assisted Reproduction, Exempt
FDA definition
This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
6

Clearances, product code PUB

By decision year
1 clearance under product code PUB with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUB by decision year
YearClearances
20201

Applicants with the most clearances

Product code PUB
Applicants holding the most 510(k) clearances under product code PUB
ApplicantClearances
CooperSurgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order