Cleared Traditional

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (K983200) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K983200 · Ximed/Prosure/Injectx · General & Plastic Surgery device
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Dec 1998
Decision
88d
Days
Class 1
Risk

K983200 is an FDA 510(k) clearance for the INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Ximed/Prosure/Injectx (San Jose, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 88 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 Ximed/Prosure/Injectx devices

Submission Details

510(k) Number K983200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date December 11, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 106
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