EXN · Support, Hernia
Gastroenterology, Urology · 21 CFR 876.5970 · Class 1
Overview
| Product Code | EXN |
|---|---|
| Device Name | Support, Hernia |
| Regulation | 21 CFR 876.5970 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
| GMP Exempt | Yes |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K901922 | SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 | Safte S.P.A. | Oct 26, 1990 | SESE |
Top Applicants
- Safte S.P.A. — 1 clearance
