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Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122968

by Coloplast Corp.

Identifiers

510(k) Number
K122968 FDA 510(k)
FDA Product Code
OTO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a synthetic surgical mesh indicated for apical vaginal and uterine prolapse repair via transabdominal placement. It is classified as a urogynecologic mesh under the General, Plastic Surgery specialty.

The device is supplied in two model variants: Qty 1 (Model 93-6014) and Qty 3 (Model 93-6015). It received FDA 510(k) clearance (K122968) on December 18, 2012, and is regulated as a Class II medical device under regulation number 878.3300.

Frequently asked questions

What is Novasilk Mesh used for?

Novasilk Mesh is indicated for apical vaginal and uterine prolapse repair via transabdominal placement, as it is a synthetic surgical mesh designed to provide support in urogynecologic procedures.

How is Novasilk Mesh supplied and what models are available?

Novasilk Mesh is supplied in two model variants: Qty 1 (Model 93-6014) and Qty 3 (Model 93-6015), allowing clinicians to select the appropriate quantity based on surgical needs.

Is Novasilk Mesh sterile and intended for single-use or reuse?

Novasilk Mesh is supplied sterile and is intended for single-use only, as it is a synthetic implantable mesh designed for one-time surgical implantation to prevent infection and ensure device integrity.

What regulatory pathway was used for Novasilk Mesh and when was it cleared?

Novasilk Mesh received FDA 510(k) clearance (K122968) on December 18, 2012, through a traditional submission pathway, demonstrating substantial equivalence to a predicate device.

What are the storage and handling requirements for Novasilk Mesh?

Novasilk Mesh should be stored in its original sterile packaging at controlled room temperature, away from moisture and direct sunlight, to maintain sterility and material stability until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015, NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY… - FDA.report, Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015, NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coloplast Corp.

Sources (1)

  • FDA 510(k) K122968 24 fields · synced Oct 6, 2026