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510(k) K933921

ACUFLEX DISPOSABLE KNIVES by Acufex Microsurgical, Inc. — Product Code HTS

K933921 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFLEX DISPOSABLE KNIVES". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code HTS (Knife, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
August 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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 HTS

  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K873714 — BANANA KNIFE, DISPOSABLE #TM-1612 (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)
  • K873712 — STANDARD KNIFE, DISPOSABLE #TM-1610 (October 15, 1987)
  • K842820 — ARTHROSCOPY KNIVES (August 14, 1984)
  • K771851 — ARTHROSCOPE OPERATIVE KNIFE SET (October 27, 1977)

FDA data resources