Personna Disposable Scalpel

FDA 510(k) K873142 · American Safety Razor Co.

Substantially Equivalent

510(k) numberK873142

Submission

Device name
Personna Disposable Scalpel
Applicant
American Safety Razor Co.
Staunton, VA, US
Received
August 10, 1987
Decision date
September 4, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K915119Scalpel Blade Remover (Bladegard)GES · Traditional Intergrated Visual, Inc.05/05/1992SE
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

More from Primrose Medical, Inc.

510(k)DeviceDecision
K924503Personna Safety ScalpelMDM · Traditional 02/05/1993SE
K863557Blade, Surgical Preparation Razor, Straight,Single · Traditional 10/06/1986SE
K771045Blades, ScalpelGES · Traditional 06/22/1977SE

Questions and answers

When was Personna Disposable Scalpel cleared by the FDA?

Personna Disposable Scalpel (K873142) received a 510(k) decision of Substantially Equivalent on September 4, 1987, 25 days after the submission was received.

What is the product code of K873142?

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