510(k) · Cleared
ClearedNU-Gel * Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Dec 16, 1998 as substantially equivalent to K973688 (Convatec, Ltd., 1997) after an 83-day review. Its family tree reaches back 1 generation to 1997. 107 later devices descend from it.
- Decided
- Dec 16, 1998
- Review
- 83 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973688 (1997). 107 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- This deviceK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- Descendant · cites it directly · 106 of its ownK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
- Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 3 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 4 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 107 · See all- K022995Collatek HydrogelBiocore Medical Technologies, Inc. · 2002 · cites it directly106descendants
- K040019SilversealNoble Fiber Technologies · 2004 · cites it directly97descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 3 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| 0 (this device) | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| +1 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| +1 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973688 | Duoderm Control Gel Formula Border DressingSummary page 1…STATEMENT OF SUBSTANTIAL EQUIVALENCE NU-GEL* Wound Dressing is substantially equivalent and identical in function to DuoDERM* CGF Control Gel Formula Border Dressing (K973688) manufactured by ConvaTec - A Division of E.R. Squibb & Sons, Inc. INDICATIONS FOR US NU-GEL* Wound Dressing is a sterile hydro… | 1997 |
What descends from it? (107)
See all 1073 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NU-GEL” Wound Dressing is a sterile hydrogel formulation of preserved polyvinyl pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL" Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. It protects against dehydration…
Read the full statement (223 words)
NU-GEL” Wound Dressing is a sterile hydrogel formulation of preserved polyvinyl pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL" Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions.
It protects against dehydration, bacterial contamination and absorbs exudate from the wound.
NU-GEL Wound Dressing is indicated for dry, light and moderately exuding partial and full thickness wounds such as:
First and second degree bumns
Severe sunbums
Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears
NU-GEL*" Wound Dressing should be used under health care professional direction for the following indications:
Bums caused by radiation oncology procedures
Pressure ulcers Stage -V
Lower extremity ulcers
Venous ulcers
Anerial ulcers
Ulcers of mixed etiology
Diabetic ulcers
Donor sites and skin grafts
Precautions:
NU-GEL* Wound Dressing is not indicated for use on the following:
Third degree bumns
Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.
NU-GEL* Wound Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.
NU-GEL" Wound Dressing may be used under compression therapy with healthcare profession supervision..
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983362: NU-Gel * Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983362
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026