# Fiber One

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/fiber-one-gex>
- Manufacturer: [American Medical Systems](https://devicerts.com/manufacturers/american-medical-systems-inc) (United States, FDA 510(k) applicant)
- Name in the registry: FIBER ONE
- Device class: Class II (US FDA)
- FDA product code: GEX

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K100746 · decision 2010-06-11 · decision SESE · status: Active

## Recalls

- Z-0834-2011 ·  · terminated · initiated 2010-07-14: Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing

## Identifiers

- 510(k) Number: K100746 [FDA 510(k)]
- FDA product code: GEX [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Fiber One, American Medical Systems. deviCERTS medical device catalogue. https://devicerts.com/devices/fiber-one-gex (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/fiber-one-gex.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/fiber-one-gex
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.