← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KNTTubes, Gastrointestinal (And Accessories)

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5980
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
ImplantLife-sustainingGMP-exemptThird-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K253514C.R. Bard, Inc. · 510k2026-07-10
K250389Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 510k2025-04-10
K243228Convatec · 510k2025-03-28
K242336Amb Medtec · 510k2025-01-17
K242901Tools For Surgery, LLC · 510k2025-01-10
K241169Gravitas Medical, Inc. · 510k2024-11-22
K241185Avanos Medical, Inc. · 510k2024-10-25

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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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