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510(k) K890167

HOLDER, NEEDLE by Dhason Brothers, Inc. — Product Code HXK

K890167 is an FDA 510(k) premarket notification submitted by Dhason Brothers, Inc. for the device "HOLDER, NEEDLE". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code HXK (Holder, Needle; Orthopedic), a Class I device regulated under 21 CFR 888.4540. Dhason Brothers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
January 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Needle; Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Dhason Brothers, Inc.

  • K890161 — THOMPSON TYPE RASP W/TOMMY BAR (February 13, 1989)
  • K890165 — FORCEPS-ORTHOPEDIC (February 13, 1989)
  • K890166 — RONGUER-ORTHOPEDIC (February 13, 1989)
  • K890158 — RETRACTORS (February 13, 1989)
  • K890156 — IMPACTOR FOR FEMORAL HEAD (February 13, 1989)
  • K890163 — AUSTIN MOORE HALLOW CHISEL (February 13, 1989)
  • K890164 — HUDSON BRACE W/BURRS (February 13, 1989)
  • K890160 — GOUGES FOR FEMORAL HEADS (February 13, 1989)
  • K890162 — EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD (February 13, 1989)
  • K890157 — FORCEPS (February 13, 1989)

Other clearances for product code HXK

  • K872989 — MICRINS NEEDLE HOLDER (August 21, 1987)
  • K860018 — FISCHER WIRE/PIN CLAMP (February 7, 1986)
  • K801594 — ACE FISCHER EXTERNAL FIXATION DEVICE (September 9, 1980)
  • K772388 — CONVERSE-GILLIES NEEDLE HOLDER (January 20, 1978)

FDA data resources