FDA.reportPublic FDA data

OverStitch™

Primary DI
00191506049126
Brand
OverStitch™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00505450
Catalog number
M00505450
Device description
Polypropylene Suture
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
00191506060138PackageGS112In Commercial Distribution
00191506049126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506060138001915060601381915060601380191506060138
00191506049126001915060491261915060491260191506049126

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

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
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