Endoscopic Tissue Approximation Device
Gastroenterology, Urology · 21 CFR 876.1500
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Recent MDR events
3,154 adverse event reports on file
- OverStitch NXT Endoscopic Suturing SystemJul 31, 2026MalfunctionApollo Endosurgery3005099803-2026-03108
- OverStitch 2-0 Polypropylene SutureJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03109
- POLYSORBJul 31, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-02087
- N/AJul 30, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-05987
- MiniGrip Clutch GrasperJul 29, 2026MalfunctionTeleflex Medical3011137372-2026-00251
- OverStitch 2-0 Polypropylene SutureJul 29, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03088
- OverStitch Suture CinchJul 28, 2026InjuryBoston Scientific Corporation3005099803-2026-03053
- OverStitch Endoscopic Suture SystemJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03055
- OverStitch Suture CinchJul 28, 2026InjuryBoston Scientific Corporation3005099803-2026-03069
- ENDO STITCHJul 28, 2026InjuryDavis & Geck Caribe Ltd9612501-2026-02052
Event type breakdown
Recalls
4 recall events for this product code
- Boston Scientific CorporationOpen, ClassifiedAug 14, 2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Z-2961-2026 · View FDA record ↗ - Boston Scientific CorporationOpen, ClassifiedAug 14, 2026
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Z-2962-2026 · View FDA record ↗ - Covidien, LPOpen, ClassifiedJun 1, 2026
Covidien EndoStitch" Polysorb Single Use Loading Unit;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Z-2281-2026 · View FDA record ↗ - Covidien LPOpen, ClassifiedFeb 6, 2024
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm-
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Z-0986-2024 · View FDA record ↗
Registered firms
102 firms currently registered for this product code
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Boston Scientific Corporation
Coventry, RI, US
Arthrocare Corporation
Coyol Alajuela, CR
Boston Scientific Corporation
El Coyol Alajuela, CR
Boston Scientific Corporation
Marlborough, MA, US
Covidien
North Haven, CT, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Boston Scientific Limited
GALWAY, IE
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Medtronic Distribution Center
Memphis, TN, US
Transluminal
pompey Meurthe-et-Moselle, FR
Nas Med Llc Fz
DUBAI Dubayy, AE
Envision Endoscopy Inc.
Waltham, MA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Isomedix Operations Inc.
Northborough, MA, US
Teleflex Medical Llc
Morrisville, NC, US
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Sterigenics Us Llc
West Memphis, AR, US
510(k) clearances
70 clearances for this product code
- Endo Tools Therapeutics S.A.Feb 13, 2026
K252400 · Endomina EZFuse system
- Envision EndoscopyApr 17, 2025
K243750 · SimpleStitch Suturing System
- CovidienSep 8, 2023
K231240 · MaxTack Motorized Fixation Device
- Health Value Creation B.V., Trading AS Corporis MedicalAug 31, 2023
K213271 · MedicloseTM System
- Apollo Endosurgery, Inc.Jun 29, 2023
K231553 · OverStitch NXT Endoscopic Suturing System
- Endo Tools Therapeutics S.A.Dec 7, 2021
K211309 · endomina system
- Anchora Medical, Ltd.Jun 17, 2021
K201744 · Su2ura Approximation Device
- Apollo Endosurgery, Inc.Mar 2, 2021
K210266 · OverStitch Sx Endoscopic Suturing System