Cleared Traditional

K993424 - THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP

K993424 is an FDA 510(k) clearance for THE TRUE Y CLIP, manufactured by Y-Clip Associates. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K993424 · Y-Clip Associates · General & Plastic Surgery device
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Dec 1999
Decision
72d
Days
Class 2
Risk

K993424 is an FDA 510(k) clearance for the THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Y-Clip Associates (Annapolis, US). The FDA issued a Cleared decision on December 23, 1999 after a review of 72 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 Y-Clip Associates devices

FDA 510(k) Submission Details - K993424

510(k) Number K993424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date December 23, 1999
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

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 122
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K993424.
MODIFICATION TO IMPLANTABLE CLIP
K011236 · Applied Medical Resources Corp. · May 2001
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc · Jul 2000
COALESCENT SURGICAL SUTURED-CLIP
K994160 · Coalescent Surgical · Feb 2000
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
K993157 · Weck Closure Systems · Dec 1999
IMPLANTABLE CLIP FOR GENERAL SURGERY
K993135 · Applied Medical Resources · Dec 1999
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
K991002 · V. Mueller Neuro/Spine · Jun 1999