Skip to content

SerosaFuse® 7.5mm Implantable Fastener Cartridges R2375

by Endogastric Solutions, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810275013052 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SerosaFuse® 7.5mm Implantable Fastener Cartridges
Generic Name
Endoscopic suturing unit, single-use
Model / Ref / Catalog
R2375
Description
2 Cartridges, 40 Implantable Fasteners, 7.5mm Web Length
Primary DI / UDI-DI
00810275013052
FDA Product Code
ODE
GMDN Term
Endoscopic suturing unit, single-use
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: Endoscopic suturing unit, single-use

Other devices from Endogastric Solutions, Inc.

See all devices from Endogastric Solutions, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No