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510(k) K030031

SOFT TISSUE ANCHORING WASHERS by Accu-Speed, Incorporated — Product Code KGS

K030031 is an FDA 510(k) premarket notification submitted by Accu-Speed, Incorporated for the device "SOFT TISSUE ANCHORING WASHERS". The FDA issued a decision of Substantially Equivalent on January 28, 2003. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2003
Date Received
January 3, 2003
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 for product code KGS

  • K020480 — RBM (March 12, 2002)
  • K964935 — SUTURE LOCK (February 25, 1997)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • 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