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Endoscopic Tissue Approximation Device
FDA product code OCW · Class 2 · Gastroenterology, Urology
101
Registered devices
3,154
Adverse events
4
Recalls
70
510(k) clearances
Devices with this code
MINILAP — TELEFLEX INCORPORATEDAbsorbaTack — Covidien LPSILS Stitch — Covidien LPOverStitch™ — BOSTON SCIENTIFIC CORPORATIONBralon — Covidien LPMINILAP — TELEFLEX INCORPORATEDMINILAP — TELEFLEX INCORPORATEDAESCULAP — Aesculap AGNXT Tissue HeliX Pro — BOSTON SCIENTIFIC CORPORATIONSofsilk — Covidien LPOverStitch NXT ™ — BOSTON SCIENTIFIC CORPORATIONNA — BOSTON SCIENTIFIC CORPORATIONAbsorbaTack — Covidien LPDemeLENE — Demetech CorporationAbClose — MEDEON BIODESIGN, INC.Polysorb — Covidien LPN/A — ETHICON ENDO-SURGERY, LLCMINILAP — TELEFLEX INCORPORATEDOverStitch Endoscopic Suturing System — Apollo Endosurgery, Inc.Surgidac — Covidien LPPolysorb — Covidien LPMINILAP — TELEFLEX INCORPORATEDPolysorb — Covidien LPBralon — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | Boston Scientific Corporation | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. |
| 2026-07-14 | Boston Scientific Corporation | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. |
| 2026-04-15 | Covidien, LP | 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. |
| 2023-11-16 | Covidien LP | 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, compromisin |
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