Keisei Micro-Blades (Sterile and Non-Sterile)

Q: What is the product code of K863214?

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

FDA 510(k) K863214 · Keisei Medical Industrial Co., Ltd.

Substantially Equivalent

510(k) numberK863214

Submission

Device name: Keisei Micro-Blades (Sterile and Non-Sterile)
Applicant: Keisei Medical Industrial Co., Ltd.
Bethel, CT, US
Received: August 20, 1986
Decision date: September 2, 1986
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)	Device	Applicant	Decision
K032242	Personna Plus Safety Scalpel SystemGES · Traditional	Omi Manufacturing Pty., Ltd.	09/23/2003SE
K932998	Easy-OnGES · Traditional	Devon Industries, Inc.	08/18/1993SE
K923170	Los Alamos Retractable KnifeGES · Traditional	Innovative Surgical Technology, Inc.	02/18/1993SE
K915119	Scalpel Blade Remover (Bladegard)GES · Traditional	Intergrated Visual, Inc.	05/05/1992SE
K911913	Precision Glide - Enhanced Surgical BladeGES · Traditional	Bd Becton Dickinson Vacutainer Systems Preanalytic	05/13/1991SE
K900266	Sterile Carbon Steel Surgical BladeGES · Traditional	Rahn Laboratories	03/01/1990SE
K884862	Anchor Double-Edge Myringotomy BladeGES · Traditional	Anchor Products Co.	12/27/1988SE
K881638	Surgical BladeGES · Traditional	Far East Intl. Trading Corp.	06/15/1988SE
K880244	Surgical BladesGES · Traditional	Ailee C/O Havel'S, Inc.	02/10/1988SE
K873493	Ninja ScalpelGES · Traditional	Primrose Medical, Inc.	09/24/1987SE

More from Primrose Medical, Inc.

510(k)	Device	Decision
K863213	Keisei Scalpel (Sterile and Non-Sterile)GDX · Traditional	09/02/1986SE
K863212	Keisei Handles for Surgical BladesGDZ · Traditional	09/02/1986SE
K863211	Keisei Surgical Blades (Sterile & Non-Sterile)GES · Traditional	09/02/1986SE

Questions and answers

When was Keisei Micro-Blades (Sterile and Non-Sterile) cleared by the FDA?

Keisei Micro-Blades (Sterile and Non-Sterile) (K863214) received a 510(k) decision of Substantially Equivalent on September 2, 1986, 13 days after the submission was received.

What is the product code of K863214?

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