510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853291Substantially Equivalent

Gp-100 Adult Electrosurgical Ground Pad/200 & 300

ZOLL Medical Corporation, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853291 is the FDA 510(k) clearance record for GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300, a class II device, cleared for Bio-Detek, Inc. on under FDA product code HAM (Apparatus, Electrosurgical). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K853291.

Clearance record

Decision date
Received
(66 days to decision)
Product code
HAM Apparatus, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bio-Detek, Inc. 171 Forbes Blvd., Mansfield MA
Third party review
No

Clearances, product code HAM

Trailing 12 months

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

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