Cleared Traditional

K002315 - WISEBANDS SKIN CLOSURE DEVICE

K002315 is an FDA 510(k) clearance for WISEBANDS SKIN CLOSURE DEVICE, manufactured by Wisebands , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code MKY cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K002315 · Wisebands , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
227d
Days
Class 1
Risk

K002315 is an FDA 510(k) clearance for the WISEBANDS SKIN CLOSURE DEVICE. Classified as System, Skin Closure (product code MKY), Class I - General Controls.

Submitted by Wisebands , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on March 15, 2001 after a review of 227 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K002315

510(k) Number K002315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2000
Decision Date March 15, 2001
Days to Decision 227 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 115d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

MKY Device Classification - Class 1, General Controls

Product Code MKY System, Skin Closure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MKY System, Skin Closure

Devices cleared under the same product code (MKY) and FDA review panel - the closest regulatory comparables to K002315.
PROXIDERM, MODELS TN 460, TN 90 460, BK 460
K982439 · Progressive Surgical Products, Inc. · Sep 1998
PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
K970439 · Progressive Surgical Products, Inc. · Apr 1997
PHOENIX ETE TISSUE EXTENSION SYSTEM
K962144 · Phoenix Biomedical Corp. · Jan 1997
PROXIDERM (TENTATIVE)
K942425 · Progressive Surgical Products, Inc. · Nov 1994
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
K942526 · Life Medical Sciences, Inc. · Jul 1994
K002315 · WISEBANDS SKIN CLOSURE DEVICE
Download PDF FDA Summary Wisebands , Ltd.