

# LNM · Agent, Bulking, Injectable For Gastro-Urology Use

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/LNM

## Overview

- **Product Code:** LNM
- **Device Name:** Agent, Bulking, Injectable For Gastro-Urology Use
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P170023](/device/P170023.md) | Bulkamid Urethral Bulking System | Boston Scientific Corporation | Jan 28, 2020 | APPR |
| [P100014](/device/P100014.md) | SOLESTA INJECTABLE GEL | Palette Life Sciences | May 27, 2011 | APPR |
| [P040050](/device/P040050.md) | MACROPLASTIQUE IMPLANTS | Uroplasty, LLC | Oct 30, 2006 | APPR |
| [P040047](/device/P040047.md) | COAPTITE | Merz North America, Inc. | Nov 10, 2005 | APPR |
| [P030030](/device/P030030.md) | URYX URETHRAL BULKING AGENT | C.R. Bard, Inc. | Dec 16, 2004 | APWD |
| [P020006](/device/P020006.md) | ENTERYX PROCEDURE KIT | Boston Scientific Corp | Apr 22, 2003 | APWD |
| [P000029](/device/P000029.md) | DEFLUX INJECTABLE GEL | Palette Life Sciences | Sep 24, 2001 | APPR |
| [P980053](/device/P980053.md) | DURASPHERE INJECTABLE BULKING AGENT | Carbon Medical Technologies, Inc. | Sep 13, 1999 | APPR |
| [P900030](/device/P900030.md) | CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT | Allergan, Inc. | Sep 30, 1993 | APWD |

## Top Applicants

- Palette Life Sciences — 2 clearances
- Allergan, Inc. — 1 clearance
- Boston Scientific Corp — 1 clearance
- Boston Scientific Corporation — 1 clearance
- C.R. Bard, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/LNM](https://fda.innolitics.com/productcode/LNM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
