← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

DEVICE CLASS
Class II
REGULATION
21 CFR 876.4300
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
ImplantLife-sustainingGMP-exemptThird-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K260962Taewoong Medical Co., Ltd. · 510k2026-05-21
K252388Francis Medical, Inc. · 510k2025-11-26
K252889Olympus Medical Systems Corporation · 510k2025-11-25
K250945Olympus Medical Systems Corp. · 510k2025-10-17
K250351Olympus Medical Systems Corporation · 510k2025-10-10
K251104Wilson-Cook Medical · 510k2025-09-29
K251226Aqua Medical, Inc. · 510k2025-08-08
K250584Boston Scientific Corporation · 510k2025-06-11

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →