Skip to content

C015

by Micronica SRL

510(k) K192182

C015 is a Class II device made by Micronica SRL, cleared under FDA 510(k) K192182 on 17 Jan 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192182 Date17 Jan 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWB
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K192182

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K192182
UDI-DISize and differences
C015 FP XL C015
MICRONICA SRL
FP XL C01508053470960017 —On the market
C015 FP XS C015
MICRONICA SRL
FP XS C01508053470960000 —On the market

Similar devices

Other devices filed under FDA product code OWB (Interventional Fluoroscopic X-Ray System).

Other devices from Micronica SRL

  • C015

    Class IIb

  • C015 Fp Xl C015

    Class II

  • C015 Fp Xs C015

    Class II

  • C015

    Class IIb

See all devices from Micronica SRL →