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SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe

by Fehling Surgical Instruments, Inc. 510(k)

Active United States

510(k) K220981

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220981 Date20 Apr 2023ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 12 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DWP
Device Class
Class II
Regulation
21 CFR Part 870.4475
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent