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510(k) K121289

LTM-LABAROSCOPIC SURGICAL MESH by Lifecell Corp. — Product Code OXK

K121289 is an FDA 510(k) premarket notification submitted by Lifecell Corp. for the device "LTM-LABAROSCOPIC SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on August 3, 2012. 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
August 3, 2012
Date Received
April 30, 2012
Clearance Type
Traditional
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.

  • K130817 — LTN - LAPAROSCOPIC SURGICAL MESH (April 17, 2013)
  • K112534 — LIFECELL TISSUE EXPANDER (August 10, 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

  • K130817 — LTN - LAPAROSCOPIC SURGICAL MESH (April 17, 2013)

FDA data resources