Cleared Traditional

K943649 - GERTIE MARX NEEDLE

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

K943649 · Manan Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 68
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
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · Baxter Healthcare Corp · Jan 1993
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K921288 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1991