510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881796Substantially Equivalent

Umi Disposable Butterfly Style Puncture Needle

Universal Medical Instrument Corp., Ballston Spa NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881796 is the FDA 510(k) clearance record for UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE, a class I device, cleared for Universal Medical Instrument Corp. on under FDA product code DWS (Instruments, Surgical, Cardiovascular). FDA records list 21 510(k) clearances for Universal Medical Instrument Corp., from to . As of , FDA records show no recalls naming K881796.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DWS Instruments, Surgical, Cardiovascular
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Universal Medical Instrument Corp. Post Office Box 100, Ballston Spa NY
Third party review
No

Clearances, product code DWS

Trailing 12 months

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

FDA records show no clearances under product code DWS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWS, 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