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Companies / SUTUREGARD Medical
Medical device company profile

SUTUREGARD Medical

Suture-retention and skin-closure devices intended to distribute tension around surgical wounds.

Medical Device ManufacturerGeneral Medical & Patient CareSurgery & Procedural CareWound CareWound ClosureCommercial-stage
HeadquartersπŸ‡ΊπŸ‡ΈCorvallis, Oregon, United States
FoundedNot confirmed
Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.
EmployeesNot confirmed
Estimated revenueNot confirmed
Disclosed fundingUS$95,600 [11]Oregon InC grant award Β· Dec 2018
Official websitesuturegard.com β†—

Company overview

SUTUREGARD Medical offers wound-closure adjuncts designed to spread suture tension over a wider skin area. Its website describes adhesive suture-retention devices and Interlock products used in orthopedic, vascular, plastic-surgery and dermatologic procedures. The company lists a Corvallis, Oregon contact address.

The portfolio includes products previously presented under the HEMIGARD name as well as current SUTUREGARD branding. Device records identify reviewed HEMIGARD retention devices as exempt from premarket submission. Exemption and FDA registration should not be described as a 510(k) clearance or evidence of clinical superiority.

Its commercial materials address surgeons, surgical facilities and purchasing teams, with case examples and publications supporting further review. Product-specific use instructions, duration of application and wound selection matter. Leadership and founding-date accounts conflict across older sources and the connection export, so unresolved titles and dates are not asserted as verified facts.

[9][10][11][12][13]

Products & regulatory status How does MedTechIndex get this information?

Summary

Reviewed HEMIGARD ASRD and Interlock device records identify exemption from premarket submission. Exact current-brand and model mapping remains incomplete. Exemption is not FDA approval; intended use, labeling and applicable exemption limitations still govern marketing. [1][2][12][9][10][3]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [7][5]

Regulatory snapshot How to read this snapshot

U.S. FDA
0
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Suture-retention device

Interlock retention device family β†—

Retention-device family described in company materials and HEMIGARD Interlock device records. [9][2]

Exemption documented

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Commercial development

Commercial focus is surgeon adoption across specialties and wound-closure applications. Device listing establishes identity and exemption information, not comparative clinical effectiveness. [9][13]

13 Cited Sources

Accessed 10/29/2026

[1] HEMIGARD ASRD device listing and submission exemption β†—U.S. National Library of Medicine / FDA Β· regulatory database
[2] HEMIGARD Interlock device listing β†—U.S. National Library of Medicine / FDA Β· regulatory database
[3] FDA 510(k) database β€” research search β†—FDA / openFDA Β· regulatory record
[4] FDA De Novo database β€” research search β†—FDA / openFDA Β· regulatory record
[6] FDA PMA database β€” research search β†—FDA / openFDA Β· regulatory record
[8] FDA UDI database β€” research search β†—FDA / openFDA Β· regulatory record
[9] Current products and clinical applications β†—SUTUREGARD Medical Β· company website
[10] Team page and Corvallis contact address β†—SUTUREGARD Medical Β· company website
[11] SUTUREGARD reports US$95,600 Oregon InC grant β†—SUTUREGARD Medical Β· company announcement
[12] ASRD purchasing and manufacturer information β†—SUTUREGARD Medical Β· company website
[13] Company mission β†—SUTUREGARD Medical Β· company website
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