510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904013Substantially Equivalent

Spive Needle System, Modification

Pascall Medical Corp., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904013 is the FDA 510(k) clearance record for SPIVE NEEDLE SYSTEM, MODIFICATION, a class II device, cleared for Pascall Medical Corp. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list one 510(k) clearance for Pascall Medical Corp. As of , FDA records show no recalls naming K904013.

Clearance record

Decision date
Received
(33 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Pascall Medical Corp. 4857 Battery Ln., #304, Bethesda MD
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260