510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921683Substantially Equivalent

Pencil Point Spinal Needle

Hart Enterprises, Inc., Wyoming MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921683 is the FDA 510(k) clearance record for PENCIL POINT SPINAL NEEDLE, a class II device, cleared for Hart Enterprises, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 4 510(k) clearances for Hart Enterprises, Inc., from to . As of , FDA records show no recalls naming K921683.

Clearance record

Decision date
Received
(505 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
Hart Enterprises, Inc. 2131 Martindale SW, Wyoming MI
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