NEXGEL, INC.

FDA Device Registration & Listing · Langhorne, PA, US · Registration 3016807311

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016807311
FEI Number
3016807311
Entity Name
NEXGEL, INC.
City/State/Country
Langhorne, PA, US
Establishment Address
2150 Cabot Blvd W Suite B, Langhorne, PA 19047, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NEXGEL, Inc. (Owner Number: 10072529)
Owner / Operator Contact Address
2150 Cabot Blvd W Suite B, Langhorne, PA 19047, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171041
PMA Number
N/A

All Registered Proprietary Names

NEXGEL SilverSeal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2020-04-29
FRO Dressing, Wound, Drug Unknown Class U N/A 2021-03-25

Official Correspondent

Manjari Valia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEXGEL, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016807311. Last updated year: 2026. Please use registration number 3016807311 when referencing this establishment in official correspondence.
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