510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841325Substantially Equivalent

Replace-a-Tip Recharg. Low Temp.

Suncoast Medical Manufacturers, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841325 is the FDA 510(k) clearance record for REPLACE-A-TIP RECHARG. LOW TEMP., a class II device, cleared for Suncoast Medical Manufacturers, Inc. on under FDA product code HQP (Unit, Cautery, Thermal, Battery-Powered). FDA records list 31 510(k) clearances for Suncoast Medical Manufacturers, Inc., from to . As of , FDA records show no recalls naming K841325.

Clearance record

Decision date
Received
(37 days to decision)
Product code
HQP Unit, Cautery, Thermal, Battery-Powered
Regulation
21 CFR 886.4115
Device class
Class II
Review panel
Ophthalmic
Applicant
Suncoast Medical Manufacturers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HQP

Trailing 12 months

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

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