# Medical Devices; Exemptions From Premarket Notification; Class II Devices
> **Food and Drug Administration** · Final rule. · Published 2001-11-15 · Effective 2001-12-17 · 66 FR 57368
## Document
- **Document number:** 01-28563
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 57368
- **CFR reference:** 21 CFR 892
- **Publication date:** 2001-11-15
- **Effective date:** 2001-12-17
- **HHS docket:** Docket No. 01N-0238
## Abstract

The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/11/15/01-28563/medical-devices-exemptions-from-premarket-notification-class-ii-devices)
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