Sterile Carbon Steel Surgical Blade

FDA 510(k) K900266 · Rahn Laboratories

Substantially Equivalent

510(k) numberK900266

Submission

Device name
Sterile Carbon Steel Surgical Blade
Applicant
Rahn Laboratories
Bland, VA, US
Received
January 18, 1990
Decision date
March 1, 1990
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
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

More from American Safety Razor Co.

510(k)DeviceDecision
K892461Non-Sterile Latex Examination GlovesLYY · Traditional 07/28/1989SE
K881479Operation Room TowelKKX · Traditional 04/14/1988SE

Questions and answers

When was Sterile Carbon Steel Surgical Blade cleared by the FDA?

Sterile Carbon Steel Surgical Blade (K900266) received a 510(k) decision of Substantially Equivalent on March 1, 1990, 42 days after the submission was received.

What is the product code of K900266?

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