Cleared Traditional

K922614 - TURKEL THORACENTESIS SYSTEM

K922614 is an FDA 510(k) clearance for TURKEL THORACENTESIS SYSTEM, manufactured by Symbiosis Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K922614 · Symbiosis Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
58d
Days
Class 1
Risk

K922614 is an FDA 510(k) clearance for the TURKEL THORACENTESIS SYSTEM. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 58 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 Symbiosis Corp. devices

FDA 510(k) Submission Details - K922614

510(k) Number K922614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date July 30, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

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 41
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K922614.
BONE MARROW BIOPSY PROCEDURE TRAY
K930158 · Symbiosis Corp. · Jul 1993
GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE
K924501 · Symbiosis Corp. · Apr 1993
SYMBIOSIS BONE MARROW BIOPSY NEEDLE
K925416 · Symbiosis Corp. · Feb 1993
KOPAN'S TARGET
K915417 · Medical Device Technologies, Inc. · Jan 1992
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
K914608 · Dlp, Inc. · Jan 1992
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991