Cleared Traditional

K851793 - 39-260 TO 39-299 VARIOUS FOREIGN BODY F...

K851793 is an FDA 510(k) clearance for 39-260 TO 39-299 VARIOUS FOREIGN BODY F..., 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 56-day FDA review.

K851793 · Artiberia · General & Plastic Surgery device
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Jun 1985
Decision
56d
Days
Class 1
Risk

K851793 is an FDA 510(k) clearance for the 39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS. 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 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 - K851793

510(k) Number K851793 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.

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 K851793.
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
17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI
K851773 · Artiberia · Jun 1985
51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO
K851796 · Artiberia · Jun 1985
PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F
K851106 · The Huxley Instrument Corp. · Apr 1985
MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420
K851114 · The Huxley Instrument Corp. · Apr 1985