510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884553Substantially Equivalent

Stamey Needle

Cook Ob/Gyn, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884553 is the FDA 510(k) clearance record for STAMEY NEEDLE, a class I device, cleared for Cook Ob/Gyn on under FDA product code GEJ (Carrier, Ligature). FDA records list 43 510(k) clearances for Cook Ob/Gyn, from to . As of , FDA records show no recalls naming K884553.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GEJ Carrier, Ligature
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cook Ob/Gyn 1100 W. Morgan St., Spencer IN
Third party review
No

Clearances, product code GEJ

Trailing 12 months

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

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