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510(k) K841980

SIDE CUTTING SERRATED BLADE by Stainless Mfg., Inc. — Product Code HTZ

K841980 is an FDA 510(k) premarket notification submitted by Stainless Mfg., Inc. for the device "SIDE CUTTING SERRATED BLADE". The FDA issued a decision of Substantially Equivalent on August 15, 1984. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Stainless Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
May 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Stainless Mfg., Inc.

  • K841979 — 4MM CUP CURRETTE (June 19, 1984)
  • K841972 — BANANA KNIFE - K841969-LABELING (June 19, 1984)
  • K841974 — RETROGRADE KNIFE 4MM & 5MM (June 19, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841981 — 4MM & 5MM FILE (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)
  • K841982 — MENISCOTOME 4MM & 5MM (June 19, 1984)
  • K841977 — 5MM DOUGLE EDGE RING CURETTE (June 19, 1984)
  • K841976 — HOOK KNIFE 4MM & 5MM (June 19, 1984)
  • K841970 — CAMELBACK HANDLE-K841969-LABELING (June 19, 1984)

Other clearances for product code HTZ

  • K933933 — CEBOPLANE (April 15, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K853678 — KAMBIN SPINAL INSTRUMENT SET (September 24, 1985)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K841975 — ROSETTE KNIFE 4MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources