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FDA PRODUCT CODE · CLASS II

PNR — Enteral Syringes With Enteral Specific Connectors

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5980
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K252483Chirana T.Injecta,A.S. · 510k2026-07-01
K253268CMT Health PTE., Ltd. · 510k2026-04-08
K251585CMT Health PTE., Ltd. · 510k2025-07-18
K243652Cardinalhealth · 510k2024-12-19

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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