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Aaron C Size High Temperature Cautery

by Sunkey Medical Manufacturing, Inc.

510(k) K870397

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 NumberK870397 Date18 Mar 1987ClearedStatusActive

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  • Withdrawn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)

Full name
Aaron C Size(Tm) High Temperature Cautery
510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Aaron C Size High Temperature Cautery is a cautery device designed for tissue coagulation and cutting through high-temperature electrocautery. It falls under the General, Plastic Surgery advisory category and is classified under product code GEI (Electrosurgical Cautery Devices). This device delivers precise cauterization by generating high temperatures to seal blood vessels and tissues during surgical procedures.

Supplied as a single-use, disposable device, the Aaron C Size High Temperature Cautery is intended for use in medical settings such as operating rooms or procedural suites. It operates via battery power and is regulated under FDA 510(k) clearance (K870397), with a Traditional clearance pathway. The device is not MRI-safe and must be stored in a clean, dry environment prior to use, adhering to standard surgical instrument protocols.