Cleared Traditional

K903748 - ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K903748 · Downs Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
76d
Days
Class 1
Risk

K903748 is an FDA 510(k) clearance for the ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on October 31, 1990 after a review of 76 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K903748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date October 31, 1990
Days to Decision 76 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
38d faster than avg
Panel avg: 114d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDM Needle, Aspiration And Injection, Reusable
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.