Home / 510(k) Clearances / K834350

510(k) K834350

ACUFEX DREZ COMMUNICATING DRILL GUIDE by Acufex Microsurgical, Inc. — Product Code FZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
December 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Acufex Microsurgical, Inc.

  • K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS (July 10, 1996)
  • K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (June 21, 1996)
  • K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (February 15, 1996)
  • K952535 — ACUFEX ENDOBUTTON TAPE (February 8, 1996)
  • K953276 — ACUFEX TAG DELIVERY SYSTEM (October 5, 1995)
  • K953459 — ACUFEX TAG ANCHOR (August 23, 1995)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K944500 — ACUFEX PATELLAR BONE BLOCK SIZER (June 12, 1995)
  • K951859 — ACUFEX ENDOBUTTON PACK (June 9, 1995)
  • K946346 — ACUFEX TAG(R) BIOABSORBABLE ANCHORS (April 26, 1995)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K842698 — BRITISH SPINAL FUSION SET (September 12, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)