Cleared Traditional

K862404 - REFLEX(TM) CLIP APPLIER

K862404 is the FDA 510(k) clearance for REFLEX(TM) CLIP APPLIER by Richard-Allan Medical Ind., Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K862404 · Richard-Allan Medical Ind., Inc. · General & Plastic Surgery device
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Jul 1986
Decision
28d
Days
Class 2
Risk

K862404 is an FDA 510(k) clearance for the REFLEX(TM) CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on July 23, 1986 after a review of 28 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 Richard-Allan Medical Ind., Inc. devices

Submission Details

510(k) Number K862404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1986
Decision Date July 23, 1986
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 97
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K862404.
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · United States Surgical, A Division of Tyco Healthc · Aug 1988
VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER
K864350 · Ethicon, Inc. · Dec 1986
LIGACLIP 20/20* MULTIPLE CLIP APPLIER
K864102 · Ethicon, Inc. · Nov 1986
TITANIUM HEMOSTATIC CLIPS
K861922 · Pilling Co. · Jun 1986
AUTO SUTURE TITANIUM HEMOSTATIC CLIP
K853650 · United States Surgical, A Division of Tyco Healthc · Sep 1985
AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200
K851251 · Edward Weck, Inc. · Jul 1985