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510(k) K200383

Wiggins Medical Surgical Instruments by Wiggins Medical — Product Code HAE

K200383 is an FDA 510(k) premarket notification submitted by Wiggins Medical for the device "Wiggins Medical Surgical Instruments". The FDA issued a decision of Substantially Equivalent on July 21, 2020. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2020
Date Received
February 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

Other clearances for product code HAE

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  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (March 3, 2023)
  • K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur (October 7, 2022)
  • K210741 — KLS Martin Neuro Rongeurs (June 3, 2022)
  • K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (May 4, 2021)
  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • K180949 — Steribite (November 8, 2018)
  • K161744 — Symmetry Sharp Kerrison Rongeur (September 7, 2016)
  • K153243 — Fehling-Punches (August 4, 2016)

FDA data resources