510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240071Substantially Equivalent

Peleton Universal Single Use Power System and Attachments

Peleton Surgical, Scottsdale AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240071 is the FDA 510(k) clearance record for Peleton Universal Single Use Power System and Attachments, a class I device, cleared for Peleton Surgical on under FDA product code SAM (Battery-Powered Instruments Charged Through Sterile Barriers). FDA's definition for product code SAM reads: "Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill...". FDA records list one 510(k) clearance for Peleton Surgical. As of , FDA records show no recalls naming K240071.

Clearance record

Decision date
Received
(85 days to decision)
Product code
SAM Battery-Powered Instruments Charged Through Sterile Barriers
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Peleton Surgical 1435 N. Hayden Rd., Scottsdale AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAM

Trailing 12 months

FDA records hold no clearances under product code SAM in the trailing twelve months.

FDA records show no clearances under product code SAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260