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General product information, not medical advice. Dressing choice and use belong to the treating clinician and the manufacturer’s instructions for use.
Short answer
Silvercel is a brand name for sterile silver alginate wound dressings. The product is a non-woven pad of alginate, carboxymethylcellulose and silver-coated nylon fibres. Its non-adherent version adds a perforated contact layer. FDA records show two 510(k) clearances under the name, K024298 and K081363, both under product code FRO.
Definition and scope
Silvercel is a trade name, not a generic category. The 510(k) summary for K081363 (decision 24 September 2008, Substantially Equivalent) names the device “SILVERCEL Non-Adherent Antimicrobial Alginate Dressing”, submitted by Advanced Medical Solutions Limited of Winsford, Cheshire, UK, with a footnote that the name is a trademark of Johnson & Johnson. In openFDA’s UDI database the labelers listed are Advanced Medical Solutions Limited and 3M Deutschland GmbH, so the brand has carried different company names over time.
It belongs to the wider family covered in What Is a Medical Dressing?. For other named silver or alginate products see Silverlon, Maxorb and Melgisorb.
How it is described in the FDA record
The K081363 summary describes a “sterile, non woven pad composed of a high G (guluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres, laminated to a perforated, non-adherent ethylene methyl acrylate (EMA) wound contact layer”. The stated functions are absorbing exudate, intact removal and keeping a moist wound environment. The indication reads that the dressing is an effective barrier to bacterial penetration, and that this barrier “may help reduce infection” in moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds. It is “indicated for external use only”.
Composition and the non-adherent layer
| Component (per K081363) | What the summary calls it |
|---|---|
| High-G alginate | Alginate with a high guluronic acid content, part of the absorbent pad |
| Carboxymethylcellulose (CMC) | Pad component alongside the alginate |
| Silver-coated nylon fibres | The silver-containing element of the pad |
| Perforated EMA layer | Ethylene methyl acrylate wound contact layer, the only change in the 2008 modification |
The summary says the modification was “the addition of a perforated, non-adherent wound contact layer”. For a general explanation of that feature see What Is a Non-Adherent Dressing?.
Silvercel versus Silvercel Non-Adherent
This is the point most listings blur. FDA and UDI records separate two versions.
| Item | Plain Silvercel | Silvercel Non-Adherent |
|---|---|---|
| 510(k) in UDI records | K024298 | K081363 (predicate K024298) |
| Catalog numbers in UDI records | 800112, 800202, 800404, 800408 | 900112, 900202, 900404, 900408 |
| Contact layer | Not part of the K081363 modification | Perforated EMA layer added |
The catalog-number split (800xxx plain, 900xxx non-adherent) comes from openFDA UDI records read on 8 November 2026 for the listed 3M Deutschland GmbH and Advanced Medical Solutions entries. Catalog numbers alone are not unique: the same digits (800112 and 900112 included) are also used by unrelated products from other manufacturers, and 800112 appears in the records read only under the 3M Deutschland GmbH entry, so match on brand, description and 510(k) number together. openFDA states its data is unvalidated and not for medical decisions, so use it for identification only and confirm against the product label.
FDA product code FRO
K081363 lists the classification name “Dressing, Wound, Drug”, product code FRO, and a classification of “Unclassified”. UDI records show device class “U”, single use and sterile. Both Silvercel clearances are 510(k)s; the summary lists the classification as unclassified rather than Class I, II or III.
Label cautions to check
A product profile published by Wounds UK (manufacturer profile) lists the following, which are worth checking against the current label for any specific pack:
- Not indicated where there is known sensitivity to alginates, ethylene methyl acrylate or silver.
- Not indicated for surgical implantation, or for pregnant or lactating women.
- Not intended to control heavy bleeding.
- Very limited data exists on prolonged and repeated use of silver-containing dressings, particularly in children and neonates.
- Suitable for use under medical supervision, including in infected wounds or wounds at increased risk of infection.
- Non-adherent UDI records show MRI safety status “MR Unsafe”; some older records state that the labeling has no MRI safety information.
The same profile cites a manufacturer-referenced claim of sustained silver ion release for up to 7 days; that is a manufacturer claim, not an FDA finding.
Where it matters for labs, clinics and supply decisions
For supply staff, the useful discipline is identification: a purchasing or protocol record that says only “Silvercel” does not show which clearance, catalog number or labeler applies. Recording the 510(k) number and catalog number resolves that. Comparisons of how silver and plain alginate differ in general terms are in calcium alginate vs silver alginate and Aquacel Ag vs calcium alginate.
Common misunderstandings
- “Silvercel is one product.” The records show at least two versions under separate clearances.
- “The brand owner is fixed.” The 510(k) names Advanced Medical Solutions as submitter with a Johnson & Johnson trademark footnote, while UDI records list 3M Deutschland GmbH as a labeler.
- “Cleared means proven to prevent infection.” The indication is a barrier to bacterial penetration that “may help reduce infection”; it is not a guarantee.
FAQ
What is Silvercel?
A brand of sterile silver alginate wound dressing, made from high-G alginate, CMC and silver-coated nylon fibres, cleared by FDA through 510(k).
What is the difference between Silvercel and Silvercel Non-Adherent?
The non-adherent version (K081363) adds a perforated EMA wound contact layer to the earlier dressing (K024298).
Is Silvercel for external use only?
Yes. The K081363 summary states it is indicated for external use only.
Is Silvercel MRI safe?
UDI records for the non-adherent dressing list it as MR Unsafe; check the label of the specific product.
Sources
- FDA 510(k) summary K081363, decision 24 September 2008: accessdata.fda.gov/cdrh_docs/pdf8/K081363.pdf (read 8 November 2026).
- openFDA device UDI and 510(k) APIs, brand name silvercel: open.fda.gov/apis/device (queried 8 November 2026).
- Wounds UK, Silvercel Non-Adherent product profile: wounds-uk.com product profile PDF (read 8 November 2026).
