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OverStitch™ M00505530

by Boston Scientific

OverStitch M00505530 is a suture/ligature tightener (FDA Class II; FDA product code OCW, Endoscopic tissue approximation device) made by Boston Scientific, listed in FDA GUDID since 17 Feb 2025 (UDI-DI 00191506060046), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00191506060046 UDI-DI Date17 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
OverStitch™
Generic name
Suture/ligature tightener, single-use
Model / Ref / Catalog
M00505530
Primary DI / UDI-DI
00191506060046
FDA product code
OCW
GMDN term
Suture/ligature tightener, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Suture/ligature tightener, single-use

Similar devices

Other devices filed under FDA product code OCW (Endoscopic tissue approximation device).

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)