Device Atlas

The Fugo Blade for Glaucoma

Q: What is the product code of K041019?

The FDA product code is NCR – Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.

FDA 510(k) K041019 · Medisurg , Ltd.

Substantially Equivalent

510(k) numberK041019

Submission

Device name: The Fugo Blade for Glaucoma
Applicant: Medisurg , Ltd.
Norristown, PA, US
Received: April 20, 2004
Decision date: October 8, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NCR – Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.4100
Specialty: Ophthalmic

Other 510(k)s with product code NCR

510(k)	Device	Applicant	Decision
K050933	Fugo Blade for Peripheral Iridotomy, Model M300NCR · Traditional	Medisurg , Ltd.	12/09/2005SE
K001498	The Fugo BladeNCR · Traditional	Medisurg , Ltd.	08/10/2000SE

More from Medisurg , Ltd.

510(k)	Device	Decision
K063468	The Fugo Blade for DentistryEKZ · Traditional	04/18/2007SE
K050933	Fugo Blade for Peripheral Iridotomy, Model M300NCR · Traditional	12/09/2005SE
K001498	The Fugo BladeNCR · Traditional	08/10/2000SE

Questions and answers

When was The Fugo Blade for Glaucoma cleared by the FDA?

The Fugo Blade for Glaucoma (K041019) received a 510(k) decision of Substantially Equivalent on October 8, 2004, 171 days after the submission was received.

What is the product code of K041019?

The FDA product code is NCR – Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4100.