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510(k) K221818

Rebellion; Phantom Multi-Bite Kerrison Rongeur by Morpheus AG — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
June 23, 2022
Clearance Type
Special
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 by Morpheus AG

  • K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (March 3, 2023)
  • K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (May 4, 2021)

Other clearances for product code HAE

  • K242759 — Geister K-Rex rongeurs (June 6, 2025)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (March 3, 2023)
  • 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)
  • K200383 — Wiggins 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)