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510(k) K220981

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe by Fehling Surgical Instruments, Inc. — Product Code DWP

K220981 is an FDA 510(k) premarket notification submitted by Fehling Surgical Instruments, Inc. for the device "SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe". The FDA issued a decision of Substantially Equivalent on April 20, 2023. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2023
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

Other clearances for product code DWP

  • K183438 — Geomed Vascular Dilators (September 3, 2019)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)
  • K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES (September 18, 1991)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)
  • K905159 — FLO-RESTER(R) VESSEL SIZER (February 7, 1991)

FDA data resources