Cleared Traditional

K811086 - SUTURE REMOVAL SET(DISPLSABLE)

K811086 is an FDA 510(k) clearance for SUTURE REMOVAL SET(DISPLSABLE), manufactured by Cunningham Woodland, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K811086 · Cunningham Woodland, Inc. · General & Plastic Surgery device
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May 1981
Decision
10d
Days
Class 1
Risk

K811086 is an FDA 510(k) clearance for the SUTURE REMOVAL SET(DISPLSABLE). Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Cunningham Woodland, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Cunningham Woodland, Inc. devices

FDA 510(k) Submission Details - K811086

510(k) Number K811086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date May 01, 1981
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 32
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K811086.
STERILE SUTURE REMOVAL SET
K832047 · Ormed Mfg., Inc. · Sep 1983
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981
LARGE WOUND DRESSING KIT
K803119 · American Medical Disposable, Inc. · Dec 1980
CUSTOM DRESSING TRAY WET TO DRY
K803117 · American Medical Disposable, Inc. · Dec 1980
SIMPLE DRESSING TRAY #82028
K803118 · American Medical Disposable, Inc. · Dec 1980