Cleared Traditional

K851750 - 7-103

K851750 is an FDA 510(k) clearance for 7-103, manufactured by Artiberia. The device is a Class 1 General & Plastic Surgery device with product code GDZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K851750 · Artiberia · General & Plastic Surgery device
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Jun 1985
Decision
56d
Days
Class 1
Risk

K851750 is an FDA 510(k) clearance for the 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7. Classified as Handle, Scalpel (product code GDZ), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 56 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 Artiberia devices

FDA 510(k) Submission Details - K851750

510(k) Number K851750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 20, 1985
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

GDZ Device Classification - Class 1, General Controls

Product Code GDZ Handle, Scalpel
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 - GDZ Handle, Scalpel

Devices cleared under the same product code (GDZ) and FDA review panel - the closest regulatory comparables to K851750.
BEAVER(R) HANDLE
K884512 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1988
SCALPEL HANDLE #3 SS 410 OR 420
K852711 · The Huxley Instrument Corp. · Jul 1985
SCALPEL HANDLE #7 SS 410 OR 420
K852735 · The Huxley Instrument Corp. · Jul 1985
I.M. SCALPEL HANDLE
K810720 · Instrument Makar, Inc. · Apr 1981
SURGICAL BLADE HANDLES
K761035 · Parke-Davis Co. · Dec 1976