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510(k) K972308

MEDNEXT 1000 DRILL by Mednext, Inc. — Product Code GEY

K972308 is an FDA 510(k) premarket notification submitted by Mednext, Inc. for the device "MEDNEXT 1000 DRILL". The FDA issued a decision of Substantially Equivalent on August 20, 1997. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Mednext, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
June 20, 1997
Clearance Type
Traditional
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 Mednext, Inc.

  • K983092 — TRITON HUDSON CHUCK ATTACHMENT (November 6, 1998)
  • K970023 — MEDNEXT SURGICAL BUR (February 28, 1997)
  • K943108 — MEDNEXT MICRO-DRILL (August 17, 1994)
  • K935861 — MEDNEXT BUR (May 3, 1994)
  • K935584 — MEDNEXT BUR (February 22, 1994)
  • K926547 — MEDNEXT 1000 BONE DISSECTING SYSTEM (July 22, 1993)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • 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