Home / 510(k) Clearances / K941740

510(k) K941740

ACUFEX ROTATOR CUFF FIXATION BUTTON by Acufex Microsurgical, Inc. — Product Code KGS

K941740 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX ROTATOR CUFF FIXATION BUTTON". The FDA issued a decision of Substantially Equivalent on June 30, 1995. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1995
Date Received
April 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retention Device, Suture
Device Class
Class I
Regulation Number
878.4930
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)
  • 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)
  • K941709 — ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS (April 14, 1995)

Other clearances for product code KGS

  • K030031 — SOFT TISSUE ANCHORING WASHERS (January 28, 2003)
  • K020480 — RBM (March 12, 2002)
  • K964935 — SUTURE LOCK (February 25, 1997)
  • K930675 — MITEK CONE WASHER (November 9, 1993)
  • K904435 — VENTROFIL TENSION RELIEF SUTURE SET (August 29, 1991)
  • K911225 — TRAY DOUGH (April 17, 1991)
  • K904136 — SUTURE TENSION ADJUSTMENT REEL (October 2, 1990)
  • K902001 — SURGICAL RETENTION BAR (May 9, 1990)
  • K896310 — ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (November 20, 1989)
  • K893995 — DERMACARE TIE HOLDER (August 11, 1989)

FDA data resources