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510(k) K100984

XYLOS VESSEL GUARD by Xylos Corporation — Product Code OMR

K100984 is an FDA 510(k) premarket notification submitted by Xylos Corporation for the device "XYLOS VESSEL GUARD". The FDA issued a decision of SESU on July 7, 2010. The device falls under product code OMR (Vessel Guard Or Cover), a Class II device regulated under 21 CFR 870.3470. Xylos Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
July 7, 2010
Date Received
April 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vessel Guard Or Cover
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.

Other clearances by Xylos Corporation

  • K111584 — XYLOS MACRO-POROUS SURGICAL MESH (August 25, 2011)
  • K090880 — XYLOS POROUS SURGICAL MESH (May 27, 2009)
  • K090778 — MTA PROTECTIVE SHEET (April 28, 2009)
  • K083823 — SECURIAN TISSUE REINFORCEMENT MATRIX (March 18, 2009)
  • K081882 — MODIFICATION TO XYLOS SURGICAL MESH (July 11, 2008)
  • K023237 — XYLOS SURGICAL MESH (March 18, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K974251 — X-CELL WOUND DRESSING (June 22, 1998)

Other clearances for product code OMR

  • K111048 — SYNTHES SCOUT TACK FIXATION (June 14, 2012)
  • K111137 — HYDROFIX VASO SHIELD (May 20, 2011)
  • K101805 — HYDROFIX VASO SHIELD (April 8, 2011)
  • K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
  • K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (July 28, 2010)
  • K100905 — HYDROFIX SURGICAL SHEET (June 2, 2010)
  • K093551 — PARADIS VASO SHIELD (December 24, 2009)
  • K090022 — PARADIS VASO SHIELD (April 20, 2009)
  • K082782 — REPLICATION MEDICAL VESSEL GUARD (April 2, 2009)

FDA data resources