← Product Code [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW) · K963015 # SURGICAL STAPLE MARKER DEVICE (MODIFY) (K963015) _Biopsys Medical, Inc. · GDW · Oct 7, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K963015 ## Device Facts - **Applicant:** Biopsys Medical, Inc. - **Product Code:** [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW.md) - **Decision Date:** Oct 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4750 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended 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. ## Device Story Surgical Staple Marker; non-absorbable, radiopaque staple; applied to soft tissue during open or percutaneous procedures; deployed via manual appliers or surgical instruments; provides radiographic visualization of surgical site; assists clinicians in post-operative localization of tissue; benefits patient by enabling precise follow-up imaging or secondary interventions. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Non-absorbable, radiopaque material; manual deployment via surgical instruments; form factor designed for soft tissue application; compatible with standard radiographic imaging. ## Regulatory Identification An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - BMI Surgical Staple Marker - Ethicon Titanium Staple - Ethicon Multifeed Stapler (Endopath EMS) - Ethicon LIGACLIP ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} OCT -7 1996 K963015 # APPENDIX V ## Summary of Safety and Effectiveness ## DETERMINATION OF SUBSTANTIAL EQUIVALENCE The BMI Surgical Staple Marker is substantially equivalent to many staple/marker devices including the BMI Surgical Staple Marker and Ethicons' Titanium Staple, Stapler (Endopath EMS), and LIGACLIP. The BMI device has the same intended use as the marketed predicate devices; these devices' intended use are to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location. The BMI Surgical Staple Marker has technologic characteristics which are substantially equivalent to the BMI and Ethicon predicate devices. ## COMPANY AND CONTACT PERSON Biopsys Medical, Inc. (BMI) 3 Morgan Irvine, CA 92618 Mark A. Cole, Ph.D. 714-460-7800 ## DEVICE NAME Surgical Staple Marker ## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE 1. BMI Surgical Staple Marker 2. Ethicon Surgical Staplers (Titanium Staples, Multifeed Stapler, LIGACLIP) ## STATEMENT OF INTENDED 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. ## STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES 1. The BMI Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location. 2. The Ethicon Staple/Clip's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location. 510(k) Notification Biopsys Medical, Inc. July 24, 1996 CONFIDENTIAL Page 34 {1} K 963015 (P. 2 OF 2) # STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE The design, construction, materials, nominal specifications are either identical or substantially equivalent to the marketed predicate devices. The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments. 510(k) Notification Blopsys Medical, Inc. July 24, 1996 CONFIDENTIAL Page 35 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K963015](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K963015) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com