Cleared Traditional

K936207 - ENDO-NEEDLE INSTRUMENT

K936207 is an FDA 510(k) clearance for ENDO-NEEDLE INSTRUMENT, manufactured by Gerard Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K936207 · Gerard Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
169d
Days
Class 1
Risk

K936207 is an FDA 510(k) clearance for the ENDO-NEEDLE INSTRUMENT. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Gerard Medical, Inc. (Charlton, US). The FDA issued a Cleared decision on June 16, 1994 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gerard Medical, Inc. devices

FDA 510(k) Submission Details - K936207

510(k) Number K936207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date June 16, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
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 24
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K936207.
BIOACCESS MARROW HARVEST SYSTEM
K971114 · Bioaccess, Inc. · Jun 1997
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K953082 · Baxter Healthcare Corp · Sep 1995
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
K930160 · Symbiosis Corp. · Jul 1993
BECTON DICKINSON MODIFIED MENGHINI NEEDLE
K915572 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
NA NEEDLES
K904667 · Olympus Corp. · Dec 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
K903747 · Downs Surgical , Ltd. · Oct 1990