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Via Surgical , Ltd.

US

Last updated May 27, 2026

What Via Surgical , Ltd. makes

Via Surgical, Ltd. manufactures bioabsorbable and non-bioabsorbable soft-tissue and mesh anchors, designed for surgical fixation in tissue repair procedures. They also produce endoscopic manual linear staplers, which are used for cutting and sealing tissue during minimally invasive surgeries. The anchors are intended for applications requiring secure attachment without permanent implants, while the staplers assist in precise tissue approximation.

The company’s devices are classified as Class II under regulatory frameworks, with submissions documented through FDA 510(k) and UDI registries. These products are listed for use in the United States, adhering to applicable medical device regulations. The manufacturer operates within the regulatory scope of the US market.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Via Surgical, Ltd. manufacture?

Via Surgical, Ltd. specializes in two primary categories of devices: bioabsorbable and non-bioabsorbable soft-tissue/mesh anchors, which are used for securing tissues during surgical repairs without leaving permanent implants. Additionally, they produce endoscopic manual linear staplers, designed for cutting and sealing tissue in minimally invasive surgeries. These devices are tailored for procedures requiring precise fixation or tissue approximation.

Where is Via Surgical, Ltd. based, and what regulatory frameworks apply to its devices?

Via Surgical, Ltd. is based in the United States. Its devices are classified as Class II under FDA regulations, indicating moderate risk and requiring pre-market submissions. The company’s products are documented in the FDA 510(k) registry (for premarket notifications) and the FDA Unique Device Identifier (UDI) system, ensuring traceability and compliance with US medical device regulations.

Which regulatory registries list Via Surgical, Ltd.’s devices?

Via Surgical, Ltd.’s devices are listed in the FDA 510(k) registry, which tracks premarket submissions for Class II devices requiring clearance before commercial distribution. Additionally, they are included in the FDA UDI (Unique Device Identifier) database, which standardizes device identification for tracking, labeling, and regulatory purposes. These registries reflect compliance with US medical device authorization requirements.

How are Via Surgical, Ltd.’s devices classified under regulatory standards?

Via Surgical, Ltd.’s devices fall under Class II classification in the US regulatory framework. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness. Examples include anchors and staplers, which undergo 510(k) premarket notifications to demonstrate substantial equivalence to legally marketed predicate devices before authorization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
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Phone
+18009696331
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
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DUNS Number
600319250

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
FasTouch™ Absorbable FTA25
FDA UDI
Class IIActive
TissueTak™ AR-19021TT
FDA UDI
Class IIActive
FasTouch™ FTPC10
FDA UDI
Class IIActive
FasTouch™ SFTPC10
FDA UDI
Class IIActive
TissueTak™ AR-19021TT-1
FDA UDI
Class IIActive
TissueTak™ AS-19022TT
FDA UDI
Class IIActive
FasTouch™ SFTP25
FDA UDI
Class IIActive
FasTouch™ Absorbable FTAC10
FDA UDI
Class IIActive
FasTouch™ Absorbable SFTA25
FDA UDI
Class IIActive
FasTouch™ Absorbable SFTAC10
FDA UDI
Class IIActive
TissueTak™ AS-19021TT
FDA UDI
Class IIActive
FasTouch™ FTP25
FDA UDI
Class IIActive
TissueTak device K203117
FDA 510(k)
Class IIActive
Fastouch Fixation System K132698
FDA 510(k)
Class IIActive
FasTouch Absorbable Fixation System K181668
FDA 510(k)
Class IIActive
FasTouch Fixation System K162252
FDA 510(k)
Class IIActive

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