510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K160366Substantially Equivalent

Electrosurgical disposable grounding pads

Top-rank Health Care Co.,Ltd., Shaoxing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160366 is the FDA 510(k) clearance record for Electrosurgical disposable grounding pads, a class II device, cleared for Top-Rank Health Care Co., Ltd. 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 4 510(k) clearances for Top-Rank Health Care Co., Ltd., from to . As of , FDA records show no recalls naming K160366.

Clearance record

Decision date
Received
(192 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
Top-Rank Health Care Co., Ltd. Checun Village, Dongguan St., Shangyu District, Shaoxing, CN
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