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510(k) K152734

Kerrison Rongeurs by Vitalitec Medizintechnik GmbH — Product Code HAE

K152734 is an FDA 510(k) premarket notification submitted by Vitalitec Medizintechnik GmbH for the device "Kerrison Rongeurs". The FDA issued a decision of Substantially Equivalent on June 18, 2016. 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
June 18, 2016
Date Received
September 22, 2015
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

  • 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)
  • 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)
  • K200383 — Wiggins Medical Surgical Instruments (July 21, 2020)
  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • K180949 — Steribite (November 8, 2018)
  • K161744 — Symmetry Sharp Kerrison Rongeur (September 7, 2016)

FDA data resources