Skip to content

Lone Star Medical Products

United Statesfrom the FDA registration address FDA establishment FEI 1627186

Devices
6
Registrations
FDA
FDA recalls
3

What Lone Star Medical Products makes

Lone Star Medical Products manufactures surgical instruments and accessories for urological procedures, including the Scott Dialmenzert, an implantable device for urethral reconstruction, and the Inguinal Reservoir Insertion tool for bladder augmentation. The company also produces the Urethral Cutter Clamp, Scott’s Surgical Retractor and Elastic for tissue manipulation, and the P-3 Closing Instrument for wound closure. Additional offerings include the Surgical Isolation Barrier System, designed to maintain sterile field integrity during procedures.

The company’s products are classified under FDA’s Class I regulatory category, requiring 510(k) clearance for market authorisation. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

  • The Scott Dialmenzensert Ref K810915

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • The Inquinal Resorvoir Inserter Ref K802983

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Urethal Cutter Clamp Ref K820015

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Scotts Surgical Retractor And Elastic Ref K791665

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Surgical Isolation Barrier System Ref K831531

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • P-3 Closing Instrument Ref K850041

    Active Regimes: 510(k) Registry: 510(k) Class:—

Company details

FDA FEI number
1627186
Address
11211 Cash Rd, Stafford, TX, 77477

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by Lone Star Medical Products, initiated on 2004-10-06. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 6 Oct 2004 Z-0212-2007 Unclassified (pre-2012) Terminated Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received. Distribution: World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong,…
      Full distribution text World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
    • 6 Oct 2004 Z-0213-2007 Unclassified (pre-2012) Terminated Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received. Distribution: World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong,…
      Full distribution text World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
    • 6 Oct 2004 Z-0214-2007 Unclassified (pre-2012) Terminated Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received. Distribution: World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong,…
      Full distribution text World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.

Frequently asked questions

How many devices does Lone Star Medical Products have in the registry?

The registry currently lists 6 devices for Lone Star Medical Products. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lone Star Medical Products's devices?

Among its 6 most recently registered devices, Lone Star Medical Products has devices listed in FDA 510(k) (6 devices).

What risk classes do Lone Star Medical Products's devices fall under?

Among its 6 most recently registered devices, the classes recorded for Lone Star Medical Products's devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Lone Star Medical Products?

FDA recall records list 3 recalls initiated by Lone Star Medical Products, the most recent initiated on 6 Oct 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Lone Star Medical Products in the registry?

The most recently registered devices listed for Lone Star Medical Products include THE SCOTT DIALMENZENSERT, THE INQUINAL RESORVOIR INSERTER, URETHAL CUTTER CLAMP and SCOTTS SURGICAL RETRACTOR AND ELASTIC.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.