# Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
> **Food and Drug Administration** · Final order. · Published 2017-01-06 · Effective 2017-01-06 · 82 FR 1598
## Document
- **Document number:** 2016-31862
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 1598
- **CFR reference:** 21 CFR 884
- **Publication date:** 2017-01-06
- **Effective date:** 2017-01-06
- **HHS docket:** Docket No. FDA-2014-N-0297
## Abstract

The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as "specialized surgical instrumentation for use with urogynecologic surgical mesh." FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/01/06/2016-31862/obstetrical-and-gynecological-devices-reclassification-of-surgical-instrumentation-for-use-with)
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