Remeex System for Urinary Incontinence

Q: What is the product code of K033310?

The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K033310 · Specialities Remeex International, S.L.

Substantially Equivalent

510(k) numberK033310

Submission

Device name: Remeex System for Urinary Incontinence
Applicant: Specialities Remeex International, S.L.
Minneapolis, MN, US
Received: October 14, 2003
Decision date: January 15, 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: OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

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Questions and answers

When was Remeex System for Urinary Incontinence cleared by the FDA?

Remeex System for Urinary Incontinence (K033310) received a 510(k) decision of Substantially Equivalent on January 15, 2004, 93 days after the submission was received.

What is the product code of K033310?

The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.