Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4022](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4022) → NAE — Dressing, Wound, Hydrogel Without Drug And/Or Biologic # NAE · Dressing, Wound, Hydrogel Without Drug And/Or Biologic _General, Plastic Surgery · 21 CFR 878.4022 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE ## Overview - **Product Code:** NAE - **Device Name:** Dressing, Wound, Hydrogel Without Drug And/Or Biologic - **Regulation:** [21 CFR 878.4022](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4022) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9. ## Recent Cleared Devices (20 of 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K083721](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K083721.md) | MODIFICATION TO ZENIEVA | River'S Edge Pharmaceuticals, LLC | Jan 8, 2009 | SESE | | [K082865](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K082865.md) | MODIFICATION TO ZENIEVA | Gorbec Pharmaceutical Services, Inc. | Oct 23, 2008 | SESE | | [K073246](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K073246.md) | ZENIEVA | Gorbec Pharmaceutical Services, Inc. | Jul 23, 2008 | SESE | | [K992094](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K992094.md) | GILTECH PLUS HYDROGEL SKIN DRESSING | Giltech Plus, Inc. | Sep 17, 1999 | SESE | | [K991061](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K991061.md) | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | Jun 28, 1999 | SESE | | [K972646](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K972646.md) | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | Ludlow Technical Products | Aug 21, 1997 | SESE | | [K971597](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K971597.md) | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | Coloplast Corp. | Jul 29, 1997 | SESE | | [K962352](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K962352.md) | HYDROGEL SKIN DRESSING | North American Sterilization & Packaging Co. | Aug 2, 1996 | SESE | | [K952945](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K952945.md) | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | Sherwood Medical Co. | Aug 23, 1995 | SN | | [K951166](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K951166.md) | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Bioderm, Inc. | Jun 21, 1995 | SESE | | [K950412](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K950412.md) | CURAGEL HYDROGEL WOUND DRESSING | Kendall Healthcare Products Co. Div.Of Tyco Health | Mar 24, 1995 | SESE | | [K945832](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K945832.md) | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS | Brady Medical Products Co. | Mar 1, 1995 | SESE | | [K942748](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K942748.md) | INTRASITE | Smith & Nephew United, Inc. | Jun 29, 1994 | SN | | [K941019](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K941019.md) | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING | Brady Medical Products Co. | May 4, 1994 | SN | | [K935848](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K935848.md) | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING | Brady Medical Products Co. | Feb 15, 1994 | SN | | [K935705](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K935705.md) | ALLEVYN ISLAND WOUND DRESSING | Smith & Nephew United, Inc. | Feb 15, 1994 | SESE | | [K934601](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K934601.md) | NDM HYDROGAUZE WOUND DRESSING | Ndm Acquisition Corp. | Feb 15, 1994 | SESE | | [K932336](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K932336.md) | NU-GEL ISLAND WOUND DRESSING | Johnson & Johnson Medical, Inc. | Feb 9, 1994 | SESE | | [K931618](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K931618.md) | DUODERM HYDROCOLLOID GEL | Convatec, A Division of E.R. Squibb & Sons | Dec 10, 1993 | SESE | | [K926508](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K926508.md) | INTRASITE GEL | Smith & Nephew United, Inc. | Jul 13, 1993 | SESE | ## Top Applicants - Brady Medical Products Co. — 4 clearances - Smith & Nephew United, Inc. — 3 clearances - Ndm Acquisition Corp. — 2 clearances - Medtronic Vascular — 2 clearances - Gorbec Pharmaceutical Services, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE) **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. 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