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510(k) K904136

SUTURE TENSION ADJUSTMENT REEL by Surgical Systems, Inc. — Product Code KGS

K904136 is an FDA 510(k) premarket notification submitted by Surgical Systems, Inc. for the device "SUTURE TENSION ADJUSTMENT REEL". The FDA issued a decision of Substantially Equivalent on October 2, 1990. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930. Surgical Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1990
Date Received
September 6, 1990
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 Surgical Systems, Inc.

  • K802868 — ACCU-COUNTER SURGICAL SPONGE COUNTING SY (December 19, 1980)

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)
  • 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