510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K072045Substantially Equivalent

Oncontrol Bone Marrow Biopsy System

Teleflex Medical, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072045 is the FDA 510(k) clearance record for ONCONTROL BONE MARROW BIOPSY SYSTEM, a class II device, cleared for Vidacare Corporation on under FDA product code KNW (Instrument, Biopsy). FDA records list 80 510(k) clearances for TELEFLEX MEDICAL, from to . As of , FDA records show no recalls naming K072045.

Clearance record

Decision date
Received
(89 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vidacare Corporation 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to November 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260
November 20260