> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Surgical Staplers Reclassified from Class 1 to Class 2
- URL: https://www.fdaweb.com/surgical-staplers-reclassified-from-class-1-to-class-2/
- Published: 2019-04-23T12:00:00.000Z
- Updated: 2026-09-15T01:22:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143930

*Federal Register* notice: FDA is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for “manual surgical instrument for general use” and assigned the product code GAG) from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The reclassification is related to risks identified in a 3/8 letter to healthcare providers that informed them about misuse of surgical staplers and provided recommendations for reducing adverse events associated with the devices. The letter also recommended that users carefully follow the stapler manufacturer’s instructions for use and provided additional recommendations for selecting the appropriate staple sizes and tissue types appropriate for the stapler. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-08260.pdf?ref=fdaweb.com).