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510(k) K941681

ARTHREX CIRCULAR HARVESTING SAW by Arthrex, Inc. — Product Code HSZ

K941681 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "ARTHREX CIRCULAR HARVESTING SAW". The FDA issued a decision of Substantially Equivalent on August 25, 1994. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1994
Date Received
April 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Arthrex, Inc.

  • K260018 — Arthrex FiberButton (June 26, 2026)
  • K260809 — Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (June 25, 2026)
  • K253931 — Arthrex Bioabsorbable PushLock Suture Anchors (May 28, 2026)
  • K254215 — Arthrex Beaming System (May 8, 2026)
  • K252016 — Arthrex Humeral Nails (March 20, 2026)
  • K260561 — Arthrex FiberTak Suture Anchor (March 20, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)

Other clearances for product code HSZ

  • K991588 — EMS SWISS ORTHOCLAST (July 21, 1999)
  • K972860 — CURVTEK TSR SYSTEM (October 31, 1997)
  • K970345 — ALIGNMENT INSTRUMENT (April 29, 1997)
  • K955084 — ASPACH 65,000 (MODIFICATION) (January 17, 1996)
  • K954080 — SODEM HIGH SPEED SYSTEM (October 16, 1995)
  • K944590 — ETHICON DRILL BIT AND DRILL GUIDE (May 11, 1995)
  • K934336 — SPINALPLANE (March 10, 1995)
  • K940276 — FILTER, DIFFUSER (November 16, 1994)
  • K942760 — PNEUMATIC WIRE TENSIONER (September 6, 1994)
  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)

FDA data resources