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Rovers Spatula

by Rovers Medical Devices B.V.

510(k) K002520

Rovers Spatula is a medical device (FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by Rovers Medical Devices B.V., cleared under FDA 510(k) K002520 on 13 Nov 2000, active as of 10 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 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK002520 Date13 Nov 2000ClearedStatusActive

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  • Withdrawn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
HHT
Device class
Class II
Regulation
21 CFR Part 884.4530
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code HHT (Spatula, Cervical, Cytological).

Other devices from Rovers Medical Devices B.V.

See all devices from Rovers Medical Devices B.V. →