Cleared Traditional

K940208 - AESCULAP ACCU-DERMATOME

K940208 is an FDA 510(k) clearance for AESCULAP ACCU-DERMATOME, manufactured by Aesculap, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFD cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K940208 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
41d
Days
Class 1
Risk

K940208 is an FDA 510(k) clearance for the AESCULAP ACCU-DERMATOME. Classified as Dermatome (product code GFD), Class I - General Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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.

FDA 510(k) Submission Details - K940208

510(k) Number K940208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1994
Decision Date February 24, 1994
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

GFD Device Classification - Class 1, General Controls

Product Code GFD Dermatome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - GFD Dermatome

All 11
Devices cleared under the same product code (GFD) and FDA review panel - the closest regulatory comparables to K940208.
DERMTOME BLADE
K962371 · Dsp Worldwide · Aug 1996
DECA DERMATOME (MICROMOTOR SYSTEM)
K945594 · Depuy Intl., Ltd. · Jun 1995
PADGETT AIR DERMATOME, MODEL A
K951085 · Padgett Instruments, Inc. · May 1995
ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K862669 · U. S. Diagnostics, Inc. · Oct 1986
SKIN MESH DEVICE
K861285 · Precision Modified Devices · Apr 1986
MASH DERMATOME
K861138 · Mecron Medical Products, Inc. · Apr 1986
K940208 · AESCULAP ACCU-DERMATOME
Download PDF FDA Summary Aesculap, Inc.