PBQ

8 FDA 510(k) clearances · Product code

FDA profile

Official device name

Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

Device class

Class II (moderate risk)

Regulation

21 CFR 884.4530

Medical specialty

Obstetrics/Gynecology

Flags

Implant

FDA definition

Attaching suture or stapling ligaments of the pelvic floor.

Adverse events (MAUDE)

2023: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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