510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022257Substantially Equivalent

Vomed Peripheral Vascular Accessories, Models 1010 Xxx-7090 Xxx & 9006 Xxx-9011 Xxx

Vomed Volzer Medizintechnik GmbH & Co., Amsterdam, Nh, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022257 is the FDA 510(k) clearance record for VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX, a class II device, cleared for Vomed Volzer Medizintechnik GmbH & Co. on under FDA product code DRC (Trocar). FDA records list 3 510(k) clearances for Vomed Volzer Medizintechnik GmbH & Co., from to . As of , FDA records show no recalls naming K022257.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Applicant
Vomed Volzer Medizintechnik GmbH & Co. Amstel 320-I, Amsterdam, Nh, NL
510(k) summary
Statement
Third party review
No

Clearances, product code DRC

Trailing 12 months

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

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