510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K950159Substantially Equivalent

Suresharp

Gainor Medical U.S.A., Inc., Mcdonough GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950159 is the FDA 510(k) clearance record for SURESHARP, a class II device, cleared for Gainor Medical U.S.A., Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 2 510(k) clearances for Gainor Medical U.S.A., Inc., from to . As of , FDA records show no recalls naming K950159.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Gainor Medical U.S.A., Inc. 2205 Hwy. 42 N., Mcdonough GA
510(k) summary
Statement
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260