Identifiers
- 510(k) Number
- K003949 FDA 510(k)
- FDA Product Code
- OCW 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 Tacker, Model R65-933 is an endoscopic tissue approximation device. It is a surgical instrument designed to deploy a helical fastener and a nonabsorbable suture to approximate tissue during endoscopic procedures.
This device is intended for use in hospital settings and is introduced into the body through a trocar sleeve. It features a 45cm stainless steel delivery tube and is supplied as a single-use instrument. The device has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the Tacker R65-933?
The Tacker R65-933 is an endoscopic tissue approximation device. It is designed to assist surgeons during endoscopic procedures by deploying a helical fastener and a nonabsorbable suture to approximate tissue.
Is this device intended for reuse?
No, the Tacker R65-933 is supplied as a single-use instrument. It is designed to be used for a single procedure and must be disposed of afterward to ensure patient safety and device performance.
How is the device introduced into the body?
The device is designed for use in hospital settings and is introduced into the body through a trocar sleeve. It features a 45cm stainless steel delivery tube to facilitate this endoscopic access.
What is the regulatory status of this device?
The Tacker, Model R65-933 has received FDA 510(k) clearance. This indicates that the device has been reviewed and cleared for market by the FDA under the traditional 510(k) pathway.
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: TACKER, MODEL R65-933 (K003949) — FDA 510(k) | Innolitics, TACKER, MODEL R65-933 510 (k) K003949 - FDA.report, Tacker, Model R65-933 - Beudamed, A & A Medical, Inc. - FDA 510 (k) Cleared Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003949 | Class II | Active |
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Manufacturer
- Manufacturer
- A & A Medical, Inc.
Sources (1)
- FDA 510(k) K003949 24 fields · synced Sep 27, 2026