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DAVOL ABSORBABLE FASTENER SYSTEM - 0113086

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082396

by C. R. Bard, Inc.

Identifiers

510(k) Number
K082396 FDA 510(k)
FDA Product Code
GDW FDA 510(k)
Models / Variants
(s) 0113080 FDA 510(k)
0113081 FDA 510(k)
0113082 FDA 510(k)
0113084 FDA 510(k)
0113086 FDA 510(k)
0113087 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4750 FDA 510(k)
Regulation Number
878.4750 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Davol Absorbable Fastener System is a class II implantable staple device designed for soft tissue approximation and fixation of surgical mesh to tissues. These fasteners are intended for use in both open and laparoscopic surgical procedures, providing secure attachment while being gradually absorbed by the body over time.

The system is supplied as a sterile, single-use device and is classified under product code GDW for implantable staples. It is regulated under FDA 510(k) clearance (K082396) and falls under the Special Controls for Class II devices. Models vary in size and configuration to accommodate different surgical applications, with no MRI safety restrictions noted.

Frequently asked questions

What types of surgical procedures can the Davol Absorbable Fastener System be used for, and how does it differ from traditional staples?

The Davol Absorbable Fastener System is designed specifically for soft tissue approximation and securing surgical mesh to tissues during both open and laparoscopic procedures. Unlike traditional staples, these fasteners are absorbable, meaning they gradually dissolve in the body over time, eliminating the need for removal. This makes it particularly useful in applications where long-term fixation isn’t required or where leaving permanent staples could cause irritation or complications.

Are the Davol Absorbable Fastener System models interchangeable, or do they have specific applications based on size?

The system includes multiple models (0113080, 0113081, 0113082, 0113084, 0113086, 0113087) that vary in size and configuration to accommodate different surgical needs. While they share the same core function, the variations allow for flexibility in tissue types, mesh attachment, and procedural requirements. Always refer to manufacturer guidelines to ensure the correct model is selected for the intended application.

How should the Davol Absorbable Fastener System be stored, and is it reusable?

The Davol Absorbable Fastener System is supplied as a sterile, single-use device. It must be stored according to the manufacturer’s instructions to maintain sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is designed for single-use, reusing the system is not recommended and could compromise patient safety.

Can the Davol Absorbable Fastener System be used in patients who require MRI scans, and what are its regulatory approvals?

The system does not have any noted MRI safety restrictions, meaning it can be used in patients who require MRI scans post-surgery. Regulatory-wise, it holds FDA 510(k) clearance (K082396) under the Special Controls for Class II devices, ensuring it meets established safety and effectiveness standards for implantable staples.

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: Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082 ..., K082396 FDA 510 (k) - DAVOL ABSORBABLE FASTENER SYSTEM, DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S)… - FDA.report, PDF K082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081 ..., K082396 FDA 510 (k) - DAVOL ABSORBABLE FASTENER SYSTEM

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) K082396 24 fields · synced Sep 19, 2026