Cleared Traditional

K943649 - GERTIE MARX NEEDLE

K943649 is an FDA 510(k) clearance for GERTIE MARX NEEDLE, manufactured by Manan Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K943649 · Manan Medical Products, Inc. · Anesthesiology device
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Mar 1995
Decision
237d
Days
Class 2
Risk

K943649 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 Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 237 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 Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K943649

510(k) Number K943649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date March 22, 1995
Days to Decision 237 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
97d slower than avg
Panel avg: 140d · This submission: 237d
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 118
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K943649.
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312 · Sherwood Medical Co. · May 1995
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · Sherwood Medical Co. · May 1995
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K951265 · Sherwood Medical Co. · Apr 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
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003 · Rusch, Inc. · Apr 1993