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510(k) K943635

ULTRA-LINE RONGEUR by V. Mueller Neuro/Spine — Product Code HAE

K943635 is an FDA 510(k) premarket notification submitted by V. Mueller Neuro/Spine for the device "ULTRA-LINE RONGEUR". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. V. Mueller Neuro/Spine has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1994
Date Received
July 27, 1994
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 by V. Mueller Neuro/Spine

  • K002276 — PSI SKULL CLAMP (August 29, 2000)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K991959 — PSI TITANIUM ANEURYSM CLIP (January 6, 2000)
  • K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP (June 11, 1999)
  • K972750 — TAKA ANEURYSM CLIP (July 9, 1998)
  • K964402 — VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM (January 23, 1997)
  • K942601 — PSI FLEXIBLE ARM (December 27, 1994)

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