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# Manual Percutaneous Surgical Set is Class 2
- URL: https://www.fdaweb.com/manual-percutaneous-surgical-set-is-class-2/
- Published: 2021-12-17T12:00:00.000Z
- Updated: 2026-09-14T17:26:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150801

*Federal Register* notice: FDA is classifying the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 (special controls). The action is based on a de novo classification request by Ethicon Endo-Surgery for its Percutaneous Surgical Set with 5mm or 10mm Attachments. The agency identified it as a prescription device consisting of a percutaneous surgical set used as a means to penetrate soft tissue to access certain areas of the abdomen. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-17/pdf/2021-27317.pdf?ref=fdaweb.com).