510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121268Substantially Equivalent

Wandy Dispersvie Electrode

Bio-Med USA, Inc., Paterson NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121268 is the FDA 510(k) clearance record for WANDY DISPERSVIE ELECTRODE, a class II device, cleared for Bio-Med USA, Inc. on under FDA product code ODR (Electrosurgical Patient Return Electrode). FDA's definition for product code ODR reads: "Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the...". FDA records list 11 510(k) clearances for Bio-Med USA, Inc., from to . As of , FDA records show no recalls naming K121268.

Clearance record

Decision date
Received
(238 days to decision)
Product code
ODR Electrosurgical Patient Return Electrode
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bio-Med USA, Inc. 111 Ellison St., Paterson NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODR

Trailing 12 months

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

FDA records show no clearances under product code ODR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODR, 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