Safe Guard

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812722 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Shutt Universal Stress Post

  Class I

  FDA 510(k) K833624 Active Cleared 28 Nov 1983

• Dental Stain Remover

  Class I

  FDA 510(k) K761352 Active Cleared 3 Jan 1977

• Thornton Anterior Chamber Irrigator

  Class I

  FDA 510(k) K771732 Active Cleared 28 Sep 1977

• Esa Camera

  Class I

  FDA 510(k) K823516 Active Cleared 30 Dec 1982

• Vitreous Suction Cutter

  Class II

  FDA 510(k) K761353 Active Cleared 5 Jan 1977

• Suture Retention Clamp

  Class I

  FDA 510(k) K771554 Active Cleared 2 Sep 1977

See all devices from Concept, Inc. →

• What is the intended use of the Safe Guard device?

  The Safe Guard is a medical device classified under the general and plastic surgery specialty. It is designed to function within the scope of its designated product code, GEI.

• How was the Safe Guard authorized for use?

  The device was authorized via FDA 510K clearance under the traditional submission process. It received a decision of Substantially Equivalent on November 5, 1981, and is identified by the K-number K812722.

• Who is the manufacturer of the Safe Guard?

  The Safe Guard is manufactured by Concept, Inc., located in McHenry, Illinois. The company submitted the device for review under the traditional 510K process.