Cleared Special

K232594 - CATHTONG™ II PICC Catheter (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232594 · L&Z Us, Inc. · General Hospital
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Sep 2023
Decision
28d
Days
Class 2
Risk

K232594 is an FDA 510(k) clearance for the CATHTONG™ II PICC Catheter. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by L&Z Us, Inc. (Norwood, US). The FDA issued a Cleared decision on September 22, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all L&Z Us, Inc. devices

Submission Details

510(k) Number K232594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2023
Decision Date September 22, 2023
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 301
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