← Product Code [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW) · K913411

# DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING (K913411)

_Davis & Geck, Inc. · GDW · Sep 6, 1991 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K913411

## Device Facts

- **Applicant:** Davis & Geck, Inc.
- **Product Code:** [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW.md)
- **Decision Date:** Sep 6, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4750
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K913411](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K913411)

**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