Cleared Traditional

K851728 - 2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS

K851728 is an FDA 510(k) clearance for 2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS, manufactured by Artiberia. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K851728 · Artiberia · General & Plastic Surgery device
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Jul 1985
Decision
67d
Days
Class 1
Risk

K851728 is an FDA 510(k) clearance for the 2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 67 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 - K851728

510(k) Number K851728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date July 01, 1985
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

Product Code GEN Forceps, General & Plastic Surgery
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 - GEN Forceps, General & Plastic Surgery

All 58
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K851728.
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
K853015 · The Huxley Instrument Corp. · Jul 1985
IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS
K852717 · The Huxley Instrument Corp. · Jul 1985
CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420
K852730 · The Huxley Instrument Corp. · Jul 1985
NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410
K852531 · The Huxley Instrument Corp. · Jun 1985
15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST
K851771 · Artiberia · Jun 1985
17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS
K851772 · Artiberia · Jun 1985