← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OPP — Pump, Infusion, Insulin Bolus

The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5725
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K252757Cequr SA · 510k2026-04-10
K243273Cequr SA · 510k2024-11-13

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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