Cleared Traditional

K080674 - PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K080674 · PAJUNK GmbH Medizintechnologie · General & Plastic Surgery device
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May 2008
Decision
60d
Days
Class 1
Risk

K080674 is an FDA 510(k) clearance for the PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM. Classified as Device, Percutaneous, Biopsy (product code MJG), Class I - General Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on May 9, 2008 after a review of 60 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 PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K080674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date May 09, 2008
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 114d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJG Device, Percutaneous, Biopsy
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.