Fiber Optic Endoillumination Probe

Q: What is the product code of K982462?

The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.

FDA 510(k) K982462 · Microvision, Inc.

Substantially Equivalent

510(k) numberK982462

Submission

Device name: Fiber Optic Endoillumination Probe
Applicant: Microvision, Inc.
Seabrook, NH, US
Received: July 15, 1998
Decision date: September 14, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FFS – Image, Illumination, Fiberoptic, For Endoscope
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Specialty: Gastroenterology, Urology

Other 510(k)s with product code FFS

510(k)	Device	Applicant	Decision
K072521	Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional	Cook Urological, Inc.	11/20/2007SE
K061622	PS SeriesFFS · Traditional	Photonic Optische Gerate Gesmbh & Cokg	03/05/2007SE
K063309	Tru-CableFFS · Traditional	Truphatek International, Ltd.	01/12/2007SE
K061025	Accutech Endolite ProbeFFS · Traditional	Accutech Medical Technologies, Inc.	05/31/2006SE
K023633	Sovis Optique's Endoscopic CableFFS · Traditional	Sovis Optique	12/31/2002SE
K001698	Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional	Cogent Light Technologies, Inc.	07/17/2000SE
K994084	Smith & Nephew Xenon Light Sources and AccessoriesFFS · Traditional	Smith & Nephew, Inc.	01/20/2000SE
K991323	Smith & Nephew Subcutaneous IlluminatorFFS · Traditional	Smith & Nephew, Inc.	07/06/1999SE
K983714	Solartec Source 270, Model # 90123FFS · Traditional	Cogent Light Technologies, Inc.	12/23/1998SE
K980636	Fiber Optic Endoillumination ProbeFFS · Traditional	Dutch Ophthalmic USA, Inc.	05/20/1998SE

More from Dutch Ophthalmic USA, Inc.

510(k)	Device	Decision
K030940	Nomad ND1000M Augmented Vision SystemGCJ · Traditional	04/09/2003SE
K022186	Scleral Plugs, 19 and 20 GaugeLXP · Traditional	02/26/2003SE
K023481	Microvision Scleral Buckling ComponentsHQX · Traditional	01/08/2003SE

Questions and answers

When was Fiber Optic Endoillumination Probe cleared by the FDA?

Fiber Optic Endoillumination Probe (K982462) received a 510(k) decision of Substantially Equivalent on September 14, 1998, 61 days after the submission was received.

What is the product code of K982462?

The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.