Cleared Traditional

K901438 - SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE

K901438 is an FDA 510(k) clearance for SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE, manufactured by Telemed Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K901438 · Telemed Systems, Inc. · General & Plastic Surgery device
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May 1990
Decision
59d
Days
Class 1
Risk

K901438 is an FDA 510(k) clearance for the SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 59 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K901438

510(k) Number K901438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date May 24, 1990
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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 48
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K901438.
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991
BONE MARROW BIOPSY TRAY
K912074 · Manan Medical Products, Inc. · Aug 1991
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES
K910036 · Surgical Technologies, Inc. · Apr 1991
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · Dlp, Inc. · Jan 1990
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · E-Z-Em, Inc. · Dec 1989