Flexilux II Cystoscope and Hysteroscope

FDA 510(k) K060899 · Schoelly Imaging, Inc.

Substantially Equivalent

510(k) numberK060899

Submission

Device name
Flexilux II Cystoscope and Hysteroscope
Applicant
Schoelly Imaging, Inc.
Worcester, MA, US
Received
April 3, 2006
Decision date
March 2, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FAJ – Cystoscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Flexilux II Cystoscope and Hysteroscope cleared by the FDA?

Flexilux II Cystoscope and Hysteroscope (K060899) received a 510(k) decision of Substantially Equivalent on March 2, 2007, 333 days after the submission was received.

What is the product code of K060899?

The FDA product code is FAJ – Cystoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.