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FDA PRODUCT CODE · CLASS II

PBQ — Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

Attaching suture or stapling ligaments of the pelvic floor.

DEVICE CLASS
Class II
REGULATION
21 CFR 884.4530
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K260380Escala Medical, Ltd. · 510k2026-03-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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