510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240185Substantially Equivalent

Cypris eXact Suture Placement Device

Cypris Medical, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240185 is the FDA 510(k) clearance record for Cypris eXact Suture Placement Device, a class I device, cleared for Cypris Medical on under FDA product code GEJ (Carrier, Ligature). FDA records list 2 510(k) clearances for Cypris Medical, from to . As of , FDA records show no recalls naming K240185.

Clearance record

Decision date
Received
(101 days to decision)
Product code
GEJ Carrier, Ligature
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cypris Medical 4541 N. Ravenswood Ave., #202, Chicago IL
510(k) summary
Summary PDF
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