510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882013Substantially Equivalent

Soft Tissue Biopsy Device

Ocean Medical Products, Ltd., Wyoming MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882013 is the FDA 510(k) clearance record for SOFT TISSUE BIOPSY DEVICE, a class I device, cleared for Ocean Medical Products, Ltd. on under FDA product code DWO (Needle, Biopsy, Cardiovascular). FDA records list 9 510(k) clearances for Ocean Medical Products, Ltd., from to . As of , FDA records show no recalls naming K882013.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DWO Needle, Biopsy, Cardiovascular
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ocean Medical Products, Ltd. 2131 Martindale, Wyoming MI
Third party review
No

Clearances, product code DWO

Trailing 12 months

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

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