Question 1

Who is the manufacturer of AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS?

Accepted Answer

American Medical Systems, Inc. filed the 510(k) submission for AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS (K896941).

Question 2

What is the FDA product code for AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS?

Accepted Answer

FAE. It is classified under 21 CFR 876.3630 as a Class 2 device in the Gastroenterology, Urology panel.

Question 3

When was AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS cleared by the FDA?

Accepted Answer

Mar 6, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K896941
Device Name	AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
Applicant	American Medical Systems, Inc.
Product Code	FAE · Gastroenterology, Urology
Decision Date	Mar 6, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.3630
Device Class	Class 2

AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

Device Facts

Regulatory Classification

Identification

Special Controls