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510(k) K180949

Steribite by Rjr Surgical, Inc. — Product Code HAE

K180949 is an FDA 510(k) premarket notification submitted by Rjr Surgical, Inc. for the device "Steribite". The FDA issued a decision of Substantially Equivalent on November 8, 2018. 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
November 8, 2018
Date Received
April 11, 2018
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

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  • 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)
  • K161744 — Symmetry Sharp Kerrison Rongeur (September 7, 2016)
  • K153243 — Fehling-Punches (August 4, 2016)

FDA data resources