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510(k) K020621

ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS by Arthrocare Corp. — Product Code GEY

K020621 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS". The FDA issued a decision of Substantially Equivalent on March 28, 2002. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Arthrocare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2002
Date Received
February 26, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Arthrocare Corp.

  • K153186 — Adjustable Fixation Device (January 28, 2016)
  • K131709 — SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (October 4, 2013)
  • K130196 — SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR (February 27, 2013)
  • K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURA (July 20, 2011)
  • K111397 — TITAN TI SUTURE ANCHOR SYSTEM (July 12, 2011)
  • K110781 — 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTR (May 27, 2011)
  • K110183 — ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (February 16, 2011)
  • K110164 — 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL (February 7, 2011)
  • K101437 — SPEEDFIX SUTURE SYSTEM (October 29, 2010)
  • K102262 — ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (October 21, 2010)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)
  • K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (August 14, 1996)

FDA data resources