510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081713Substantially Equivalent

Vertebral Access System by Vidacare

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

K081713 is the FDA 510(k) clearance record for VERTEBRAL ACCESS SYSTEM BY VIDACARE, a class I device, cleared for Vidacare Corporation on under FDA product code MOQ (Battery, Replacement, Rechargeable). FDA records list 80 510(k) clearances for TELEFLEX MEDICAL, from to . As of , FDA records show no recalls naming K081713.

Clearance record

Decision date
Received
(157 days to decision)
Product code
MOQ Battery, Replacement, Rechargeable
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Vidacare Corporation 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOQ

Trailing 12 months

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

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