510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030078Substantially Equivalent

Burbank Tenaculum, Model 09-0011-01

Vascular Control Systems, Inc., San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030078 is the FDA 510(k) clearance record for BURBANK TENACULUM, MODEL 09-0011-01, a class II device, cleared for Vascular Control Systems, Inc. on under FDA product code HDC (Tenaculum, Uterine). FDA records list 9 510(k) clearances for Vascular Control Systems, Inc., from to . As of , FDA records show no recalls naming K030078.

Clearance record

Decision date
Received
(15 days to decision)
Product code
HDC Tenaculum, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Vascular Control Systems, Inc. 32236 Paseo Adelanto, Suite E, San Juan Capistrano CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HDC

Trailing 12 months

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

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