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PolarCoat

by Patton Surgical Corp.

510(k) K052907

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 NumberK052907 Date16 Oct 2006ClearedStatusActive

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  • Withdrawn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
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.

PolarCoat is an anti-sticking solution designed for electrosurgical electrodes, classified under the category of electrosurgical, cutting, and coagulation accessories. It is intended to minimize adhesion and sticking during surgical procedures involving electrosurgical devices, thereby enhancing electrode performance and reducing potential complications.

This single-use device is supplied in either sponge or bottle form and is intended for one-time patient use. It is not sterile as supplied but is intended for sterile application in the surgical setting. PolarCoat has received FDA 510(k) clearance under the product code GEI, with a decision date of October 16, 2006, and is regulated as a substantially equivalent device to its predicate.

Other devices from Patton Surgical Corp.

Questions

AI-generated answers, 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.

  • What is PolarCoat used for in surgical procedures and how does it improve electrode performance?

    PolarCoat is an anti-sticking solution specifically designed for electrosurgical electrodes to minimize adhesion and sticking during surgery. By reducing electrode sticking, it helps maintain consistent performance of electrosurgical devices, which can improve precision during cutting and coagulation procedures. This can lower the risk of complications related to electrode failure or poor contact during use.

  • Is PolarCoat sterile when received, and how should it be prepared for use in the operating room?

    PolarCoat is not sterile as supplied but is intended for sterile application in the surgical setting. Before use, it must be sterilized according to standard surgical protocols to ensure it meets sterile field requirements. This typically involves autoclaving or another validated sterilization method appropriate for the sponge or bottle form.

  • What forms does PolarCoat come in, and is it intended for single-use only?

    PolarCoat is supplied in two forms: as a sponge or in a bottle. It is explicitly designed for single-use only, meaning each application should be used on one patient and then discarded. This ensures safety and compliance with medical device guidelines for patient care.

  • What regulatory pathway was followed for PolarCoat’s FDA clearance, and what does that mean for its use?

    PolarCoat received FDA clearance through a 510(k) submission, classified under product code GEI (electrosurgical accessories). The device was determined to be substantially equivalent to a predicate, meaning it was evaluated against an existing approved product with similar intended use. This clearance confirms it meets FDA safety and effectiveness standards for electrosurgical electrode accessories.