Cleared Traditional

K813422 - SCALPEL

K813422 is the FDA 510(k) clearance for SCALPEL by Abco Dealers, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDX) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K813422 · Abco Dealers, Inc. · General & Plastic Surgery device
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Jan 1982
Decision
29d
Days
Class 1
Risk

K813422 is an FDA 510(k) clearance for the SCALPEL. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1982 after a review of 29 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K813422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date January 05, 1982
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDX Scalpel, One-piece
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 - GDX Scalpel, One-piece

All 8
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K813422.
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · Imm Enterprises , Ltd. · Jan 1984
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K820869 · Van-Tec, Inc. · May 1982
MICRO CISE DIAMOND SCALPEL
K820730 · CooperVision, Inc. · Apr 1982
STERILE DISPOSABLE KNIFE
K790259 · Intermedics, Inc. · Feb 1979
SCALPEL
K780998 · Isolab, Inc. · Jul 1978