Cleared Traditional

K931644 - GERTIE MARX NEEDLE

K931644 is an FDA 510(k) clearance for GERTIE MARX NEEDLE, manufactured by Intl. Medical-Dental Products USA, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K931644 · Intl. Medical-Dental Products USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
173d
Days
Class 2
Risk

K931644 is an FDA 510(k) clearance for the GERTIE MARX NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Intl. Medical-Dental Products USA, Inc. (Park City, US). The FDA issued a Cleared decision on September 22, 1993 after a review of 173 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Medical-Dental Products USA, Inc. devices

FDA 510(k) Submission Details - K931644

510(k) Number K931644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date September 22, 1993
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 140d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 126
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K931644.
GERTIE MARX NEEDLE
K943649 · Manan Medical Products, Inc. · Mar 1995
PENCIL POINT SPINAL NEEDLE AND TRAY
K932569 · B. Braun of America, Inc. · Jan 1994
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K932400 · B. Braun of America, Inc. · Dec 1993
MEDIZIV SPINAL NEEDLE SET
K925831 · Medicia Medical Products · Jul 1993
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003 · Rusch, Inc. · Apr 1993
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · Baxter Healthcare Corp · Jan 1993