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Bard Endoscopic Suturing System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994290

by C. R. Bard, Inc.

Identifiers

510(k) Number
K994290 FDA 510(k)
FDA Product Code
ODE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard Endoscopic Suturing System is an Endoscopic Suture/Plication System designed for endoscopic placement of sutures in esophageal and gastric soft tissue. It facilitates tissue approximation through controlled suture placement, aiding in procedures related to gastroesophageal reflux disease (GERD) and other endoscopic interventions in gastroenterology and urology.

The system comprises reusable and disposable components, including a handle, capsule assembly, needle assembly, guidewire, pusher wire, and suture components. Supplied sterile for single-use, it is intended for use in endoscopic procedures within a controlled clinical setting. Authorized under FDA 510(k) clearance (K994290), it adheres to Class II regulatory standards for endoscopic suturing devices.

Frequently asked questions

What types of procedures is the Bard Endoscopic Suturing System designed to assist with, and in which specialties is it commonly used?

The Bard Endoscopic Suturing System is specifically designed for endoscopic placement of sutures in esophageal and gastric soft tissue, aiding in procedures related to gastroesophageal reflux disease (GERD) and other endoscopic interventions. It is primarily used in the specialties of gastroenterology and urology, as indicated by its advisory committee classification and medical specialty description.

Is the Bard Endoscopic Suturing System reusable, or is it intended for single-use only?

The system includes both reusable and disposable components, such as the handle, capsule assembly, needle assembly, guidewire, pusher wire, and suture components. However, the entire system is supplied sterile for single-use, meaning it should not be reused after a single procedure to maintain sterility and safety.

What components make up the Bard Endoscopic Suturing System, and how are they packaged?

The system consists of a reusable handle, a disposable capsule assembly, needle assembly, guidewire, pusher wire, and suture components. Since it is supplied sterile for single-use, these components are likely pre-assembled and packaged together in a sterile barrier system for immediate clinical use.

How was the regulatory pathway for the Bard Endoscopic Suturing System determined, and what does this mean for its use?

The device was authorized through an FDA 510(k) clearance (K994290), which means it was deemed substantially equivalent to a legally marketed predicate device. This clearance falls under Class II regulatory standards, indicating it requires special controls to ensure safety and effectiveness, but it does not require pre-market approval (PMA). Clinicians can rely on this pathway as evidence of its regulatory review and compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bard Endocinch Suturing System # 000452; 000454; 000595 (K003956) — Fda ..., 510(k) Premarket Notification, BARD ENDOSCOPIC SUTURING SYSTEM (K994290) — FDA 510 (k) | Innolitics, BARD ENDOSCOPIC SUTURING SYSTEM (K994290) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K994290 24 fields · synced Sep 19, 2026