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510(k) K130817

LTN - LAPAROSCOPIC SURGICAL MESH by Lifecell Corp. — Product Code OXK

K130817 is an FDA 510(k) premarket notification submitted by Lifecell Corp. for the device "LTN - LAPAROSCOPIC SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on April 17, 2013. The device falls under product code OXK (Mesh, Surgical, Collagen, Large Abdominal Wall Defects), a Class II device regulated under 21 CFR 878.3300. Lifecell Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2013
Date Received
March 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists in abdominal wall defects.

Other clearances by Lifecell Corp.

  • K112534 — LIFECELL TISSUE EXPANDER (August 10, 2012)
  • K121289 — LTM-LABAROSCOPIC SURGICAL MESH (August 3, 2012)
  • K082176 — LTM-BPS SURGICAL MESH (November 14, 2008)
  • K082103 — LTM WOUND DRESSING (October 8, 2008)
  • K080353 — LTM-T SURGICAL MESH (April 3, 2008)
  • K071986 — LTM-RC SURGICAL MESH (October 19, 2007)
  • K070560 — LRTM SURGICAL MESH (June 11, 2007)
  • K061208 — LIFECELL DURAL SUBSTITUTE MATRIX (January 3, 2007)
  • K052735 — ALLOCRAFT DBM (December 28, 2005)

Other clearances for product code OXK

  • K121289 — LTM-LABAROSCOPIC SURGICAL MESH (August 3, 2012)

FDA data resources