510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011800Substantially Equivalent

Vanguard Reprocessed Electric Biopsy Forceps

Stryker Sustainability Solutions, Lakeland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011800 is the FDA 510(k) clearance record for VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS, a class II device, cleared for Vanguard Medical Concepts, Inc. on under FDA product code NLU (Forceps, Biopsy, Electric, Reprocessed). FDA's definition for product code NLU reads: "The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3)...". FDA records list 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show no recalls naming K011800.

Clearance record

Decision date
Received
(111 days to decision)
Product code
NLU Forceps, Biopsy, Electric, Reprocessed
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vanguard Medical Concepts, Inc. 5307 Great Oak Dr., Lakeland FL
510(k) summary
Summary
Third party review
No

Clearances, product code NLU

Trailing 12 months

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

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