Scalpel Blade Remover (Bladegard)

FDA 510(k) K915119 · Intergrated Visual, Inc.

Substantially Equivalent

510(k) numberK915119

Submission

Device name
Scalpel Blade Remover (Bladegard)
Applicant
Intergrated Visual, Inc.
Quincy, IL, US
Received
November 13, 1991
Decision date
May 5, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GES – Blade, Scalpel
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GES

510(k)DeviceApplicantDecision
K032242Personna Plus Safety Scalpel SystemGES · Traditional Omi Manufacturing Pty., Ltd.09/23/2003SE
K932998Easy-OnGES · Traditional Devon Industries, Inc.08/18/1993SE
K923170Los Alamos Retractable KnifeGES · Traditional Innovative Surgical Technology, Inc.02/18/1993SE
K911913Precision Glide - Enhanced Surgical BladeGES · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic05/13/1991SE
K900266Sterile Carbon Steel Surgical BladeGES · Traditional Rahn Laboratories03/01/1990SE
K884862Anchor Double-Edge Myringotomy BladeGES · Traditional Anchor Products Co.12/27/1988SE
K881638Surgical BladeGES · Traditional Far East Intl. Trading Corp.06/15/1988SE
K880244Surgical BladesGES · Traditional Ailee C/O Havel'S, Inc.02/10/1988SE
K873493Ninja ScalpelGES · Traditional Primrose Medical, Inc.09/24/1987SE
K873142Personna Disposable ScalpelGES · Traditional American Safety Razor Co.09/04/1987SE

Questions and answers

When was Scalpel Blade Remover (Bladegard) cleared by the FDA?

Scalpel Blade Remover (Bladegard) (K915119) received a 510(k) decision of Substantially Equivalent on May 5, 1992, 174 days after the submission was received.

What is the product code of K915119?

The FDA product code is GES – Blade, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.