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# Arthroscopy Pump Tubing 510(k) Guidance
- URL: https://www.fdaweb.com/arthroscopy-pump-tubing-510-k-guidance/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150831

FDA has issued a guidance, *Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use—Premarket Notification (510(k)) Submissions*, with submission recommendations for these devices designed to deliver irrigation fluid to a surgical site such as the knee, shoulder, hip, elbow, ankle, and wrist joints during arthroscopic procedures. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/arthroscopy-pump-tubing-sets-intended-multiple-patient-use-premarket-notification-510k-submissions?ref=fdaweb.com) outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. It also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.

FDA says the document’s scope is limited to specified Class 2 arthroscopy pump tubing sets.

“While FDA believes the recommendations listed below serve as rigorous risk mitigation strategies for reducing the risk of cross-contamination between patients,” the guidance says, “it should be noted that the only way to eliminate the risk of cross-contamination from multiple patient use is to utilize single patient use arthroscopy pump tubing sets.”