Cleared Traditional

K864193 - GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN

K864193 is an FDA 510(k) clearance for GILBAUGH ASPIRATING BIOPSY SYRINGE/NEED..., manufactured by Gaw, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K864193 · Gaw, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
21d
Days
Class 1
Risk

K864193 is an FDA 510(k) clearance for the GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Gaw, Inc. (Portland, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 21 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 Gaw, Inc. devices

FDA 510(k) Submission Details - K864193

510(k) Number K864193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date November 17, 1986
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

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.

Regulatory Peers - GDM Needle, Aspiration And Injection, Reusable

All 25
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K864193.
SPINAL NEEDLE
K882073 · Karlin Technology, Inc. · Jul 1988
SPINAL NEEDLE
K880812 · T. Korossurgical Instruments Corp. · Mar 1988
WHOLEY (TM) BIOPSY DEVICE
K874928 · Medrad, Inc. · Dec 1987
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805 · Angiomed U.S., Inc. · Sep 1986
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
K862481 · CIVCO Medical Instruments Co., Inc. · Jul 1986
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL
K854420 · Meadox Surgimed, Inc. · Nov 1985