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510(k) K893995

DERMACARE TIE HOLDER by Dermacare — Product Code KGS

K893995 is an FDA 510(k) premarket notification submitted by Dermacare for the device "DERMACARE TIE HOLDER". The FDA issued a decision of Substantially Equivalent on August 11, 1989. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930. Dermacare has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1989
Date Received
June 5, 1989
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 Dermacare

  • K060653 — THERMACLEAR (October 24, 2006)
  • K884656 — DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP (November 25, 1988)

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)
  • 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)

FDA data resources