← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

LFLInstrument, Ultrasonic Surgical

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
SU
ImplantLife-sustainingGMP-exemptThird-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K251162Integra LifeSciences Corporation · 510k2025-10-08
K242894Shanghai Saints Sages Surgical Co., Ltd. · 510k2025-06-18
K243930Stryker Instruments · 510k2025-03-24
K241700Trice Medical, Inc. · 510k2024-11-18

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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