Cleared Traditional

K851673 - RAKA OCH BOSDA PEANGER

K851673 is an FDA 510(k) clearance for RAKA OCH BOSDA PEANGER, manufactured by General Electric Trading Co.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K851673 · General Electric Trading Co. · General & Plastic Surgery device
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May 1985
Decision
36d
Days
Class 1
Risk

K851673 is an FDA 510(k) clearance for the RAKA OCH BOSDA PEANGER. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by General Electric Trading Co. (New York, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 36 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 General Electric Trading Co. devices

FDA 510(k) Submission Details - K851673

510(k) Number K851673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date May 29, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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 69
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K851673.
17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI
K851773 · Artiberia · Jun 1985
39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS
K851793 · 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
JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42
K851116 · The Huxley Instrument Corp. · Apr 1985