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510(k) K962022

POWERCUT GOLD SURGICAL SYSTEM by Baxter Healthcare Corp — Product Code HWE

K962022 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "POWERCUT GOLD SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 5, 1996. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 5, 1996
Date Received
May 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type
510(k) Exempt

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Other clearances for product code HWE

  • K143191 — IntelliSense Drill (Feb 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (Jan 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (Jan 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (Jan 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (Sep 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (Feb 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (Feb 4, 2002)
  • K990816 — AVCORE SYSTEM (Sep 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (Dec 29, 1997)

FDA data resources

Source: FDA 510(k) database entry for K962022. Report a data issue: hello@regdatalab.com.