510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813589Substantially Equivalent

Shartpoint Eyed Needles

S. Jackson, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813589 is the FDA 510(k) clearance record for SHARTPOINT EYED NEEDLES, a class I device, cleared for S. Jackson, Inc. on under FDA product code GDL (Needle, Suturing, Reusable). FDA records list 16 510(k) clearances for S. Jackson, Inc., from to . As of , FDA records show no recalls naming K813589.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GDL Needle, Suturing, Reusable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
S. Jackson, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GDL

Trailing 12 months

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

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