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Replace-A-Tip Recharg. Low Temp.

by Suncoast Medical Manufacturers, Inc.

510(k) K841325

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841325 Date9 May 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQP
Device Class
Class II
Regulation
21 CFR Part 886.4115
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a battery-powered thermal cautery unit intended for ophthalmic procedures. It delivers controlled low-temperature thermal energy to tissue for hemostasis or minor tissue modification. The device operates using a replaceable tip and rechargeable battery system.

The device is supplied with a reusable handle and disposable tips, designed for single-patient use per tip. It is intended for use in clinical settings such as GP surgeries, theatres, and emergency departments. The device is regulated under 21 CFR 886.4115 and was cleared under FDA 510(k) K841325. Storage conditions should follow manufacturer guidelines; no MRI safety information is provided in the data.

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