Cleared Traditional

K851751 - 7-120

K851751 is an FDA 510(k) clearance for 7-120, manufactured by Artiberia. The device is a Class 1 General & Plastic Surgery device with product code GDX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K851751 · Artiberia · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
56d
Days
Class 1
Risk

K851751 is an FDA 510(k) clearance for the 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1. Classified as Scalpel, One-piece (product code GDX), 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 - K851751

510(k) Number K851751 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.

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 11
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K851751.
ICAN CYLINDRICAL SPONGES
K914086 · Icn Pharmaceuticals, Inc. · Oct 1991
CCI CORNEAL SCARIFIER
K904505 · Buckman Co., Inc. · Apr 1991
1-CUT ACL GRAFT KNIFE
K905380 · Depuy, Inc. · Dec 1990
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · Imm Enterprises , Ltd. · Jan 1984
PILLING DIAMOND KNIFE
K822749 · Narco Scientific · Oct 1982
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K820869 · Van-Tec, Inc. · May 1982