# K963015: Surgical Staple Marker Device (Modify)

- Pathway: 510(k) (Traditional)
- Applicant: Biopsys Medical, Inc.
- Decided: Oct 7, 1996 after 74 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BMI Surgical Staple Marker: named in the summary without a submission number
- (no number) Ethicon Titanium Staple: named in the summary without a submission number
- (no number) Ethicon Surgical Staplers (Endopath EMS): named in the summary without a submission number
- (no number) Ethicon LIGACLIP: named in the summary without a submission number
- (no number) Ethicon Multifeed Stapler: named in the summary without a submission number

## Indications for use
The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.

Source page: https://510kreport.com/device/K963015
Methodology: https://510kreport.com/methodology