510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896588Substantially Equivalent

Oncoprobe II System

Care Wise Medical Products Corp., Morgan Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896588 is the FDA 510(k) clearance record for ONCOPROBE II SYSTEM, a class I device, cleared for Care Wise Medical Products Corp. on under FDA product code IZD (Probe, Uptake, Nuclear). FDA records list 4 510(k) clearances for Care Wise Medical Products Corp., from to . As of , FDA records show no recalls naming K896588.

Clearance record

Decision date
Received
(113 days to decision)
Product code
IZD Probe, Uptake, Nuclear
Regulation
21 CFR 892.1320
Device class
Class I
Review panel
Radiology
Applicant
Care Wise Medical Products Corp. P.O. Box 1655, Morgan Hill CA
Third party review
No

Clearances, product code IZD

Trailing 12 months

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

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