510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042594Substantially Equivalent

Vanguard Reprocessed Non-Electric Biopsy Forceps

Stryker Sustainability Solutions, Lakeland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042594 is the FDA 510(k) clearance record for VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS, a class I device, cleared for Vanguard Medical Concepts, Inc. on under FDA product code NON (Forceps, Biopsy, Non-Electric, Reprocessed). FDA's definition for product code NON reads: "same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at...". FDA records list 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show no recalls naming K042594.

Clearance record

Decision date
Received
(124 days to decision)
Product code
NON Forceps, Biopsy, Non-Electric, Reprocessed
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Vanguard Medical Concepts, Inc. 5307 Great Oak Dr., Lakeland FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NON

Trailing 12 months

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

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