Cleared Traditional

K811707 - AXICUT DISPOSABLE SCALPEL

K811707 is an FDA 510(k) clearance for AXICUT DISPOSABLE SCALPEL, manufactured by Neonatal Corp.. The device is a Class 1 General & Plastic Surgery device with product code GDX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K811707 · Neonatal Corp. · General & Plastic Surgery device
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Jul 1981
Decision
34d
Days
Class 1
Risk

K811707 is an FDA 510(k) clearance for the AXICUT DISPOSABLE SCALPEL. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by Neonatal Corp. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 34 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 Neonatal Corp. devices

FDA 510(k) Submission Details - K811707

510(k) Number K811707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1981
Decision Date July 20, 1981
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

GDX Device Classification - Class 1, General Controls

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 13
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K811707.
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K820869 · Van-Tec, Inc. · May 1982
MICRO CISE DIAMOND SCALPEL
K820730 · CooperVision, Inc. · Apr 1982
SCALPEL
K813422 · Abco Dealers, Inc. · Jan 1982
I.M. BLADES
K800177 · Instrument Makar, Inc. · Feb 1980
STERILE DISPOSABLE KNIFE
K790259 · Intermedics, Inc. · Feb 1979
SCALPEL
K780998 · Isolab, Inc. · Jul 1978