Cleared Traditional

K911204 - QUALTEX SKIN STAPLE EXTRACTOR

K911204 is the FDA 510(k) clearance for QUALTEX SKIN STAPLE EXTRACTOR by Deroyal Industries, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDT) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K911204 · Deroyal Industries, Inc. · General & Plastic Surgery device
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May 1991
Decision
50d
Days
Class 1
Risk

K911204 is an FDA 510(k) clearance for the QUALTEX SKIN STAPLE EXTRACTOR. Classified as Staple, Removable (skin) (product code GDT), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4760 - 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 Deroyal Industries, Inc. devices

Submission Details

510(k) Number K911204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date May 08, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDT Staple, Removable (skin)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4760
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 - GDT Staple, Removable (skin)

All 11
Devices cleared under the same product code (GDT) and FDA review panel - the closest regulatory comparables to K911204.
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
K910586 · United States Surgical, A Division of Tyco Healthc · Mar 1991
APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
K900486 · Davis & Geck, Inc. · Apr 1990
SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE
K861711 · Busse Hospital Disposables, Inc. · May 1986
V. MUELLER VITAL SKIN STAPLER
K851974 · American V. Mueller · Jun 1985
VISISTAT SKIN STAPLING DEVICE
K844837 · Edward Weck, Inc. · Jan 1985
SKIN STAT II SKIN STAPLING MEDICAL DEVICE
K844838 · Edward Weck, Inc. · Jan 1985