510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963234Substantially Equivalent

Staple Removal Kit

Continental Medical Laboratories, Inc., Waterford WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963234 is the FDA 510(k) clearance record for STAPLE REMOVAL KIT, a class I device, cleared for Continental Medical Laboratories, Inc. on under FDA product code GDT (Staple, Removable (Skin)). FDA records list 8 510(k) clearances for Continental Medical Laboratories, Inc., from to . As of , FDA records show no recalls naming K963234.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GDT Staple, Removable (Skin)
Regulation
21 CFR 878.4760
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Continental Medical Laboratories, Inc. 817 W. Mohr Ave., Waterford WI
510(k) summary
Statement
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