510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K844836Substantially Equivalent

Hemoclip X-20 Automatic Hemoclip Ligating Applier

Edward Weck, Inc., Research Triangle Pa NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844836 is the FDA 510(k) clearance record for HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER, a class II device, cleared for Edward Weck, Inc. on under FDA product code GWD (Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp). FDA records list 140 510(k) clearances for Edward Weck, Inc., from to . As of , FDA records show no recalls naming K844836.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Regulation
21 CFR 866.3220
Device class
Class II
Review panel
Microbiology
Applicant
Edward Weck, Inc. P.O. Box 12600, Research Triangle Pa NC
Third party review
No

Clearances, product code GWD

Trailing 12 months

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

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