510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K931644Substantially Equivalent

Gertie Marx Needle

Intl. Medical-Dental Products USA, Inc., Park City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931644 is the FDA 510(k) clearance record for GERTIE MARX NEEDLE, a class II device, cleared for Intl. Medical-Dental Products USA, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list one 510(k) clearance for Intl. Medical-Dental Products USA, Inc. As of , FDA records show no recalls naming K931644.

Clearance record

Decision date
Received
(173 days to decision)
Product code
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Applicant
Intl. Medical-Dental Products USA, Inc. P.O. Box 681180, Park City UT
510(k) summary
Statement
Third party review
No

Clearances, product code BSP

Trailing 12 months

FDA records hold no clearances under product code BSP in the trailing twelve months.

FDA records show no clearances under product code BSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260