510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895885Substantially Equivalent

Automated Disposable Soft Tissue Biopsy Cutting

National-Standard Co., Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895885 is the FDA 510(k) clearance record for AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING, a class II device, cleared for National-Standard Co. on under FDA product code FCI (Punch, Biopsy). FDA records list one 510(k) clearance for National-Standard Co. As of , FDA records show no recalls naming K895885.

Clearance record

Decision date
Received
(127 days to decision)
Product code
FCI Punch, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
National-Standard Co. 4445-360 SW 35th Ter., Gainesville FL
Third party review
No

Clearances, product code FCI

Trailing 12 months

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

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