← Product Code [EXN](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXN) · K901922

# SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 (K901922)

_Safte S.P.A. · EXN · Oct 26, 1990 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXN/K901922

## Device Facts

- **Applicant:** Safte S.P.A.
- **Product Code:** [EXN](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXN.md)
- **Decision Date:** Oct 26, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5970
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXN/K901922](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXN/K901922)

**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