510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854095Unknown

Biopsy Tray I & II

North Coast Medi-Tek, Eastlake OH / Traditional, Unknown
FDA source (opens on fda.gov)

K854095 is the FDA 510(k) clearance record for BIOPSY TRAY I & II, a class II device, cleared for North Coast Medi-Tek on under FDA product code LRO (General Surgery Tray). FDA's definition for product code LRO reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 6 510(k) clearances for North Coast Medi-Tek, from to . As of , FDA records show 3 recalls naming K854095.

Clearance record

Decision date
Received
(49 days to decision)
Product code
LRO General Surgery Tray
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
North Coast Medi-Tek 1520-B E. 365 St., Eastlake OH
Third party review
No

Clearances, product code LRO

Trailing 12 months

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

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