FDA.reportPublic FDA data

Fascial tissue dilator, reusable

Definition
A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and made of metal (e.g., stainless steel). It is typically used for the dilatation of fascial tissue around peripheral vasculature, puncture sites, and various ducts. This is a reusable device.
GUDID devices
85
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190376681238Valence Robotic Navigation SystemALPHATEC SPINE, INC.525-9802026-03-27
M719GSIX200L0SIros-XGenesys Orthopedics Systems LLC12026-01-30
M719GSIX200M0SIros-XGenesys Orthopedics Systems LLC12026-01-30
M719GSIX200S0SIros-XGenesys Orthopedics Systems LLC12026-01-30
M719GSIX200XL0SIros-XGenesys Orthopedics Systems LLC12026-01-30
00848657078153AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SPC52026-01-20
00848657084475AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SPC102026-01-20
00848657084536AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SPC122026-01-20
07640172553619CMORE® System, Tap Sleeveicotec AG45-1602025-11-24
04580036673196KamiyamaTAKAYAMA INSTRUMENTS INC.K-5002025-06-26
00810143891348Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-NEP-420-162025-04-25
00810143891409Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-NEP-500-092025-04-25
04048551090466MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27830AA2016-09-23
04048551090480MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27830AB2016-09-23
04048551090503MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27830AC2016-09-23
04048551347522MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27820AA2018-08-21
04048551347539MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27820AB2018-08-21
04048551366639MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27840AA2018-08-21
04048551366646MIP Minimal Invasive PCNLKarl Storz GmbH & Co. KG27840AB2018-08-21
07640172552407VADER Pedicle System, Dilator Navigated, Ø 13.0 mmicotec AG42-647N2023-08-08
07640172552414VADER Pedicle System, Dilator Navigated, Ø 18.5 mmicotec AG42-648N2023-08-08
07640172552421VADER Pedicle System, Dilator Navigated, Ø 20.5 mmicotec AG42-649N2023-08-08
07640164844312VADER Pedicle System, Dilator, Ø 7.0 mmicotec AG42-6462019-08-15
07640164844329VADER Pedicle System, Dilator, Ø 13.0 mmicotec AG42-6472019-08-15
07640164844336VADER Pedicle System, Dilator, Ø 17.5 mmicotec AG42-6482019-08-15
07640164844343VADER Pedicle System, Dilator, Ø 19.5 mmicotec AG42-6492019-08-15
00827002026773CookCOOK INCORPORATEDG026772020-10-02
00887517511140ReLineNuvasive, Inc.100004172020-04-28
00887517581471ReLineNuvasive, Inc.100007912016-09-24
00887517804051XLIFNuvasive, Inc.69991002018-06-21
B073DRK0100080Kalitec SpecialKalitec Direct LLCDR-K01-00082020-01-08
B073DRK0100090Kalitec SpecialKalitec Direct LLCDR-K01-00092020-01-08
B07311K0170200CosmolockKalitec Direct LLC11-K01-70202020-01-03
00848657069519AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SP16002019-06-13
00848657069526AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.SP16012019-06-13
10889981100568Facet FixationSeaspine Orthopedics Corporation95-80172016-02-04
10889981100575Facet FixationSeaspine Orthopedics Corporation95-80182016-02-04
10889981100582Facet FixationSeaspine Orthopedics Corporation95-80192016-02-04
B07310K0191110CosmoLock Pedicle Screw SystemKalitec Direct LLC10-K01-91112018-09-14
B07310K0191120CosmoLock Pedicle Screw SystemKalitec Direct LLC10-K01-91122018-09-14
B07310K0191130CosmoLock Pedicle Screw SystemKalitec Direct LLC10-K01-91132018-09-14
B5872010010YellowstoneSUMMIT SPINE LLC12018-03-28
B5872010020YellowstoneSUMMIT SPINE LLC12018-03-28
B5872010030YellowstoneSUMMIT SPINE LLC12018-03-28
00887517063403NuVasiveNuvasive, Inc.10109662018-09-24
00887517063410NuVasiveNuvasive, Inc.10109672018-09-24
00887517063427NuVasiveNuvasive, Inc.10109682018-09-24
00887517070531StruXureNuvasive, Inc.15898682016-09-24
00887517070562StruXureNuvasive, Inc.15898752018-09-24
00887517103147StruXureNuvasive, Inc.15898602016-09-24
00887517153630PreceptNuvasive, Inc.88900222016-09-24
00887517170606NVM5Nuvasive, Inc.20299502016-10-11
00887517180445StruXureNuvasive, Inc.16566112018-09-24
00887517180858StruXureNuvasive, Inc.16569222016-10-11
00887517184399StruXureNuvasive, Inc.16565902016-10-11
00887517184412NuVasiveNuvasive, Inc.32030062018-09-24
00887517184702StruXureNuvasive, Inc.16566002016-10-11
00887517206053MaXcessNuvasive, Inc.34000302018-09-17
00887517206060MaXcessNuvasive, Inc.34000312018-09-17
00887517206077MaXcessNuvasive, Inc.34000322016-10-11
00887517226600ReLineNuvasive, Inc.100003612016-10-11
00887517231802ReLineNuvasive, Inc.100003482016-10-11
00887517231819ReLineNuvasive, Inc.100003492016-10-11
00887517326782StruXureNuvasive, Inc.15898642018-09-24
00887517349941PreceptNuvasive, Inc.88012032016-09-24
00887517349958PreceptNuvasive, Inc.88012042016-09-24
00887517349965PreceptNuvasive, Inc.88012052016-09-24
00887517350329PreceptNuvasive, Inc.88012112016-09-24
00887517351661PreceptNuvasive, Inc.88012752016-09-24
00887517352194PreceptNuvasive, Inc.88012962016-09-24
00887517352507PreceptNuvasive, Inc.88012972016-09-24
00887517503886ReLineNuvasive, Inc.100004112016-10-11
00887517503893ReLineNuvasive, Inc.100004122016-10-11
00887517504067StruXureNuvasive, Inc.16600502016-10-11
00887517511102ReLineNuvasive, Inc.100004132016-10-11
00887517511119ReLineNuvasive, Inc.100004142016-10-11
00887517511195ReLineNuvasive, Inc.100004222016-10-11
00887517512123ReLineNuvasive, Inc.100005572016-09-24
00887517512208ReLineNuvasive, Inc.100005672016-09-24
00887517512215ReLineNuvasive, Inc.100005682016-09-24