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Endoscopic Tissue Approximation Device

FDA product code OCW · Class 2 · Gastroenterology, Urology

0
Registered devices
3,286
Adverse events
4
Recalls
70
510(k) clearances

Devices with this code

endomina system — Endo Tools TherapeuticsOverStitch Endoscopic Suturing System — Apollo Endosurgery, Inc.Tacker — Covidien LPPolysorb — Covidien LPMedeon — MEDEON BIODESIGN, INC.OverStitch™ — BOSTON SCIENTIFIC CORPORATIONSimpleStitch — ENVISION ENDOSCOPY, INC.Bralon — Covidien LPAESCULAP — Aesculap AGMINILAP — TELEFLEX INCORPORATEDAESCULAP — Aesculap AGOverStitch NXT Endoscopic Suturing System — Apollo Endosurgery, Inc.NA — BOSTON SCIENTIFIC CORPORATIONAbsorbaTack — Covidien LPSimpleStitch — ENVISION ENDOSCOPY, INC.AbsorbaTack — Covidien LPSurgidac — Covidien LPMINILAP — TELEFLEX INCORPORATEDBralon — Covidien LPStat Tack — Covidien LPN/A — ETHICON ENDO-SURGERY, LLCOverStitch Endoscopic Suturing System — Apollo Endosurgery, Inc.Surgidac — Covidien LPSimpleStitch — ENVISION ENDOSCOPY, INC.

Recent recalls

DateFirmReason
2026-07-14Boston Scientific CorporationDevice may fail to deploy the cinch implant and/or fail to cut the suture as intended.
2026-07-14Boston Scientific CorporationDevice may fail to deploy the cinch implant and/or fail to cut the suture as intended.
2026-04-15Covidien, LPThe presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
2023-11-16Covidien LPPackaging 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, compromisin

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.