Surgisis Peyronie’s Repair Graft, Model SPR-100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K062320 ↗

FDA Product Code

FTM

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Hybrid Graft

  Class II

  FDA 510(k) K111695 Active Cleared 2 Apr 2012

• Sis Fistula Plug

  Class II

  FDA 510(k) K050337 Active Cleared 9 Mar 2005

• Surgisis Staple Line Reinforcement II

  Class II

  FDA 510(k) K051048 Active Cleared 23 Sep 2005

• Surgisis Rvp Recto-Vaginal Fistula Plug Open recall

  Class II

  FDA 510(k) K062729 Active Cleared 10 Oct 2006

• Oasis Wound Matrix

  Unclassified

  FDA 510(k) K061711 Active Cleared 19 Jul 2006

• Surgisis Staple Line Reinforcement

  Class II

  FDA 510(k) K022044 Active Cleared 23 Aug 2002

See all devices from Cook Biotech, Inc. →

• What is the Surgisis Peyronie’s Repair Graft SPR-100 used for?

  The Surgisis Peyronie’s Repair Graft SPR-100 is a surgical mesh designed specifically to reinforce soft tissue defects in the tunica albuginea, which are commonly associated with Peyronie’s disease. It provides structural support to weakened areas during repair procedures, helping to maintain anatomical integrity and improve surgical outcomes.

• How is the Surgisis Peyronie’s Repair Graft SPR-100 supplied and prepared for use?

  The Surgisis Peyronie’s Repair Graft SPR-100 is supplied sterile and intended for single-use only. It is packaged in a sterile barrier system to ensure sterility before opening. Clinicians should follow standard surgical protocols for mesh implantation, including aseptic techniques, to prepare and use the graft effectively.

• Is the Surgisis Peyronie’s Repair Graft SPR-100 reusable or intended for single-use?

  The Surgisis Peyronie’s Repair Graft SPR-100 is explicitly designed for single-use only. This ensures patient safety by preventing cross-contamination and maintaining the integrity of the sterile field during surgical procedures. Reuse is not recommended or supported by the manufacturer.

• What regulatory approval does the Surgisis Peyronie’s Repair Graft SPR-100 hold?

  The Surgisis Peyronie’s Repair Graft SPR-100 has received FDA 510(k) clearance (K062320) as a Class II device. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and meets regulatory standards for safety and effectiveness in its intended use for reinforcing tunica albuginea defects.

• How should the Surgisis Peyronie’s Repair Graft SPR-100 be stored before use?

  The graft should be stored in its original, unopened sterile packaging at room temperature, away from direct sunlight and moisture. Ensure the packaging remains intact until immediately before use to preserve sterility. Follow manufacturer guidelines for expiration dates and storage conditions to maintain device performance.