510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844838Substantially Equivalent

Skin Stat II Skin Stapling Medical Device

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

K844838 is the FDA 510(k) clearance record for SKIN STAT II SKIN STAPLING MEDICAL DEVICE, a class I device, cleared for Edward Weck, Inc. on under FDA product code GDT (Staple, Removable (Skin)). FDA records list 140 510(k) clearances for Edward Weck, Inc., from to . As of , FDA records show no recalls naming K844838.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GDT Staple, Removable (Skin)
Regulation
21 CFR 878.4760
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Edward Weck, Inc. P.O. Box 12600, Research Triangle Pa NC
Third party review
No

Clearances, product code GDT

Trailing 12 months

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

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