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

Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PBQ is the FDA product code for Fixation, Non-Absorbable Or Absorbable, For Pelvic Use, a class II device type, regulated under 21 CFR 884.4530. FDA's definition for this code reads: "Attaching suture or stapling ligaments of the pelvic floor". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PBQ
Device name
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
FDA definition
Attaching suture or stapling ligaments of the pelvic floor.
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code PBQ

By decision year
8 clearances under product code PBQ with a decision year between 2004 and 2026, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PBQ by decision year
YearClearances
20041
20121
20131
20161
20222
20231
20261

Applicants with the most clearances

Product code PBQ
Applicants holding the most 510(k) clearances under product code PBQ
ApplicantClearances
Escala Medical3
MEDLINE INDUSTRIES, LP - Northfield1
Ethicon, Inc1
Ibi Israel Biomedical Innovations, Ltd.1
Neomedic International S.L.1
Pop Medical Solutions1

Companies listing this code with FDA

Companies whose registered establishments list this code