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510(k) K874954

MANUAL RONGEUR by Solway, Inc. — Product Code HTX

K874954 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "MANUAL RONGEUR". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code HTX (Rongeur), a Class I device regulated under 21 CFR 888.4540. Solway, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874961 — BONE CUTTING INSTRUMENTS & ACCESSORIES (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)
  • K874959 — VASCULAR CLAMP (December 30, 1987)

Other clearances for product code HTX

  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K780397 — ORTHOPEDIC FORCEPS (March 22, 1978)
  • K760325 — SURGICAL INSTRUMENTS, ORTHOPEDIC (August 3, 1976)

FDA data resources