G Surgiwear Penile Implant
Urology

G Surgiwear Penile Implant

Pack Sizes Available

Single unit (implant set)
Available in multiple girth/length configurations

Product Description

Andrology implant surgery is a field where the margin for error is essentially zero. The patient population, the psychological stakes, and the permanence of the procedure demand a device that performs without compromise for years after implantation. G Surgiwear's penile implant is a semi-rigid malleable prosthesis from one of India's most established implant manufacturers. The company's implant engineering heritage runs deep — they are the same manufacturer responsible for a significant portion of the world's hydrocephalus shunt supply. Their experience with implantable devices is not a marketing claim. It is measurable in procedure volumes and three decades of post-market history. The semi-rigid design allows the implant to be manually positioned for intercourse and repositioned to a non-erect configuration for daily wear. It does not require a pump, reservoir, or mechanical inflation cycle, which means fewer mechanical components and fewer mechanical failure modes. For patients in markets where healthcare access for complex mechanical revisions is limited, this matters enormously. Manufactured under EN ISO 13485:2012 certification and exported to multiple countries, this device is supported by the manufacturing rigor expected of a serious implant product. Sara Wellness has 15 years of experience exporting G Surgiwear implants and surgical products to international markets. We understand the documentation requirements for Class III device importation, we know the regulatory landscape in multiple regions, and we deal with importers directly. If you are sourcing andrology implants for a distributor network or hospital chain, this conversation is worth having.

Technical Specifications

  • Device Type: Semi-rigid malleable penile prosthesis
  • Mechanism: Manually positionable, no pump or inflation required
  • Implant Location: Corpora cavernosa (bilateral)
  • Materials: Medical-grade silicone with internal malleable core
  • Available Configurations: Multiple length and girth variants
  • Sterilization: Ethylene Oxide (ETO)
  • Certification: EN ISO 13485:2012 certified manufacturer
  • Indication: Erectile dysfunction unresponsive to conservative therapy
  • Export Status: Exported to multiple international markets
FAQ

Frequently asked questions

Contact Export TeamContact Export Team

G Surgiwear manufactures a semi-rigid malleable penile implant (penile prosthesis). This type of implant is surgically placed in the corpora cavernosa and can be manually positioned for use and repositioned for concealment. It does not require a hydraulic pump or inflation mechanism.

Semi-rigid malleable implants have fewer mechanical components, which translates to a lower risk of mechanical failure compared to inflatable three-piece devices. They are simpler to implant, have a faster surgical time, and are a practical option in settings where access to complex mechanical revision surgery may be limited.

Yes. G Surgiwear manufactures under EN ISO 13485:2012 certification and exports implants to multiple international markets. Sara Wellness provides export documentation support including CE conformity records and shipping compliance documents relevant to the destination country's regulatory requirements.

The implant is available in multiple length and girth configurations to accommodate different patient anatomies. Specific size specifications and catalog numbers should be confirmed at the time of order with Sara Wellness based on clinical requirements and destination market preferences.

Penile implants from G Surgiwear are sterilized using Ethylene Oxide (ETO) sterilization, which is standard for implantable medical devices that cannot withstand steam sterilization temperatures.

Sara Wellness can assist with CE marking documentation, ISO 13485 certificates, manufacturing facility information, and other documents commonly required for medical device import registration in international markets. Requirements vary by country — contact us with your destination market and we will advise accordingly.

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