FDA.reportPublic FDA data

OverStitch™

Primary DI
00191506060046
Brand
OverStitch™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00505530
Catalog number
M00505530
Device description
Suture Cinch
Published
2025-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCWEndoscopic tissue approximation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506060046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506060046001915060600461915060600460191506060046

GMDN Terms#

Term, Definition table
TermDefinition
Suture/ligature tightener, single-useA hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. 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
08714729860853Expel™ Drainage Catheter with Twist-Loc™ HubH74939341082502016-08-17
08714729860860Expel™ Drainage Catheter with Twist-Loc™ HubH74939341102502016-08-17
08714729860877Expel™ Drainage Catheter with Twist-Loc™ HubH74939341122502016-08-17
08714729860884Expel™ Drainage Catheter with Twist-Loc™ HubH74939341142502016-08-17
08714729860891Expel™ Drainage Catheter with Twist-Loc™ HubH749393410825K12016-08-17
08714729860907Expel™ Drainage Catheter with Twist-Loc™ HubH749393411025K12016-08-17
08714729860914Expel™ Drainage Catheter with Twist-Loc™ HubH749393411225K12016-08-17
00802526623400NA694669462024-08-29
00802526604430INGEVITY™+78402020-02-06
00802526604522INGEVITY™+78422020-02-06
00802526604577INGEVITY™+78412020-02-06
00802526480546NA662866282014-09-24
00802526488900NA60402014-09-24
00802526488924NA60422014-09-24
00802526488931NA60432014-09-24
00802526496868RELIANCE 4-FRONT™06362018-08-25
00802526496967RELIANCE 4-FRONT™06652018-08-25
00802526496981RELIANCE 4-FRONT™06752018-08-25
00802526497001RELIANCE 4-FRONT™06762018-08-25
00802526523304INGEVITY™ MRI77312016-05-10

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 CORPORATIONOCW2025-09-19
00191506060053Tissue HelixBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONOCW2025-07-28
00191506049126OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506060138OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
00191506049188NABOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
14026704737946MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737953MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737960MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737977MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
24026704737943MINILAPTELEFLEX INCORPORATEDOCW2024-11-05