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. 2018 Jun 19;13(6):e0197883. doi: 10.1371/journal.pone.0197883

Table 1. Public availability of clinical and scientific evidence for the meshes that have led to over 100 off-spring devices.

Device Name Manufacturer 510K Number Date cleared Summary Evidence mentioned / Data Provided Number of descendants
Mersilene Mesh Ethicon INC - Pre 1976 - None 183
SUPPLE PERI-GUARD BIO-VASCULAR, INC. K923657 12/21/1992 No summary available None 167
BARD MARLEX MESH DART C.R. Bard, INC K922916 08/24/1992 No Summary available None 162
PROLENE PROPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC. - Pre 1976 - None 120
MODIFIED PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC. K962530 08/09/1996 Summary available
  • No clinical evidence

  • Bench testing: Only Burst strength test

119
DEXON 'S' POLYGLYCOLIC ACID MESH Davis & Geck, INC K830889 05/09/1983 No Summary available None 118
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH ETHICON, INC. K001122 05/23/2000 Summary available
  • No clinical evidence

  • Nonclinical laboratory testing was not performed

  • According to the manufacturer bench testing was performed but the details were not provided

115
TISSUE PATCH, TISSUE GRAFT BIO-VASCULAR, INC. K921895 11/04/1992 Statement available None 106
TRELEX NATURAL(R) MESH MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. K945377 12/08/1994 No summary available None 104
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH W.L. GORE & ASSOCIATES,INC K930822 01/28/1994 No summary available None 104
SURGICAL FABRICS BOSTON SCIENTIFIC CORP. K963226 11/15/1996 Summary available
  • No clinical evidence

  • According to the manufacturer bench testing was performed but details were not provided

103