Home / 510(k) Clearances / K875043

510(k) K875043

RONGEUR (NEUROSURGICAL INSTRUMENTS) by Solway, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
December 2, 1987
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 Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY (January 28, 1988)
  • K874964 — DENTAL HAND INSTRUMENTS (January 27, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874952 — MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)

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)
  • 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)