Home / 510(k) Clearances / K883299

510(k) K883299

SUTURE RETENTION DEVICE by Edwards Orthopaedics Div., Baxter Healthcare Corp. — Product Code KGS

K883299 is an FDA 510(k) premarket notification submitted by Edwards Orthopaedics Div., Baxter Healthcare Corp. for the device "SUTURE RETENTION DEVICE". The FDA issued a decision of Substantially Equivalent on August 23, 1988. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930. Edwards Orthopaedics Div., Baxter Healthcare Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1988
Date Received
August 4, 1988
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 Edwards Orthopaedics Div., Baxter Healthcare Corp.

  • K883300 — IRRIGATION SET (November 1, 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