Surgical Staple Marker Device (Modify)

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

510(k) Number

K963015 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Biopsy Device Accessory

  Class II

  FDA 510(k) K951326 Active Cleared 15 May 1995

• Retractor Arm Clamp

  Class I

  FDA 510(k) K960019 Active Cleared 9 Feb 1996

• Micromark Clip

  Class II

  FDA 510(k) K970817 Active Cleared 11 Sep 1997

• Modified Biopsy Needle

  Class II

  FDA 510(k) K951229 Active Cleared 6 Apr 1995

• Mammotome Biopsy Probe and Housing (Mammotome)

  Class II

  FDA 510(k) K970565 Active Cleared 28 Mar 1997

• Biopsy Needle and Housing

  Class II

  FDA 510(k) K942639 Active Cleared 7 Jul 1994

See all devices from Biopsys Medical, Inc. →

• What types of surgical procedures is the Surgical Staple Marker Device intended for, and how does it function during those procedures?

  The Surgical Staple Marker Device (Modify) is designed for use in open or percutaneous procedures within general and plastic surgery. It functions by being applied to soft tissue to create a radiographically visible marker, allowing surgeons to identify the exact surgical location on X-ray or other imaging studies. This helps in tracking anatomical landmarks post-surgery.

• Is the Surgical Staple Marker Device reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

  The device is explicitly labeled as a single-use item, meaning it should not be reused after one application. Since it is implantable, sterility is critical—it should be handled using aseptic techniques and opened only in a sterile field immediately before use. Unused devices must be stored in their original packaging until deployment.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?

  The Surgical Staple Marker Device (Modify) was cleared through the FDA 510(k) process under product code GDW, with a decision labeled as Substantially Equivalent (SE). This means the FDA determined it is as safe and effective as a legally marketed predicate device. Clinically, this clearance confirms its compliance with U.S. regulations for Class 2 implantable staples, ensuring it meets established safety and performance standards for surgical use.

• Are there different sizes or models of the Surgical Staple Marker Device, and if so, how would a clinician determine the appropriate one for a patient?

  The provided data does not specify distinct sizes or models of the Surgical Staple Marker Device, but it is classified as an implantable staple intended for general and plastic surgery applications. Selection would typically depend on tissue type, anatomical location, and surgeon preference, though exact sizing details would require consultation with the manufacturer or product documentation. Always verify compatibility with the patient’s procedure and tissue characteristics.