FDA.reportPublic FDA data

Tissue Helix

Primary DI
00191506060053
Brand
Tissue Helix
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00505460
Catalog number
M00505460
Device description
Tissue HeliX Pro
Published
2025-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCWEndoscopic tissue approximation device
QTDEndoscopic suturing device for altering gastric anatomy for weight loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2
QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight LossGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506060053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506060053001915060600531915060600530191506060053

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083048020SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048037SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048044SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048051SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048082SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048112SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
00850083048136SimpleStitchENVISION ENDOSCOPY, INC.OCW2026-07-17
14026704937056MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937063MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937070MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937087MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
14026704937094MINILAPTELEFLEX INCORPORATEDOCW2026-03-30
05425029282049endomina EZFuse sutureEndo Tools TherapeuticsOCW2026-03-19
05425029282087endomina EZFuse systemEndo Tools TherapeuticsOCW2026-03-19
05425029282643endomina EZFuse sutureEndo Tools TherapeuticsOCW2026-03-19
05425029282599endomina EZFuse systemEndo Tools TherapeuticsOCW2026-03-19
00860014822704EndoFix Tissue Fixation DeviceEndofix Medical Technologies, Inc.OCW2026-02-02
00860014822711Secure Suture Locking DeviceEndofix Medical Technologies, Inc.OCW2026-02-02
00191506060091OverStitch™BOSTON SCIENTIFIC CORPORATIONQTD2025-09-19
00191506060091OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-09-19
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506049126OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506060138OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506049188NABOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506060046OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
14026704737946MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737953MINILAPTELEFLEX INCORPORATEDOCW2024-11-05