Cleared Traditional

K843589 - TICLIP STERIAL DISPOSABLE

K843589 is the FDA 510(k) clearance for TICLIP STERIAL DISPOSABLE by Western Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K843589 · Western Medical Products, Inc. · General & Plastic Surgery device
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Oct 1984
Decision
42d
Days
Class 2
Risk

K843589 is an FDA 510(k) clearance for the TICLIP STERIAL DISPOSABLE. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Western Medical Products, Inc. (Van Nuys, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Western Medical Products, Inc. devices

Submission Details

510(k) Number K843589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date October 24, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 101
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K843589.
AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200
K851251 · Edward Weck, Inc. · Jul 1985
ETHICON - CHOLANGIOCLIP
K850273 · Ethicon, Inc. · Apr 1985
AUTOMATIC MULTICLIP DISPOS. LIGATING
K843336 · Davis & Geck, Inc. · Oct 1984
HEMOCLIP LIGATING CLIPS MED/SML
K841547 · Edward Weck, Inc. · Aug 1984
HEMOCLIP LIGATING CLIPS M/LARGE
K841548 · Edward Weck, Inc. · Aug 1984
HEMOCLIP AUTOMATIC CLIPS MEDIUM
K841549 · Edward Weck, Inc. · Aug 1984