FDA.reportPublic FDA data

OverStitch™

Primary DI
00191506060091
Brand
OverStitch™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00505410
Catalog number
M00505410
Device description
Endoscopic Suturing System
Published
2025-09-19
Public version status
Update
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
00191506060091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506060091001915060600911915060600910191506060091

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
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00191506060053Tissue HelixBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060053Tissue HelixBOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
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
14026704737960MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737977MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
24026704737943MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
34026704737957MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
34026704737964MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
24026704737974MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
00811955020834OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.QTD2024-10-01