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Salumedica Nerve Cuff

by Salumedica, LLC

510(k) K002098

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002098 Date24 Nov 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXI
Device Class
Class II
Regulation
21 CFR Part 882.5275
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Salumedica Nerve Cuff is a flexible tubular sheath classified as a nerve cuff, designed to serve as an interface between a peripheral nerve and its surrounding bed. It functions as a conduit to facilitate axonal growth across gaps in peripheral nerves, aiding in nerve regeneration and functional restoration following injury.

The device is supplied sterile and hydrated in saline, available in inner diameters of 2 mm, 5 mm, and 10 mm. It is intended for single-use applications in clinical settings and has received FDA 510(k) clearance under regulation 882.5275, classified as a Class II medical device. No MRI safety information or reusable specifications are noted in the available data.

Other devices from Salumedica, LLC

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Salumedica Nerve Cuff designed to do?

    The Salumedica Nerve Cuff is a flexible tubular sheath engineered to act as an interface between a peripheral nerve and its surrounding tissue. Its primary function is to serve as a conduit that facilitates axonal growth across gaps in injured peripheral nerves, promoting nerve regeneration and restoring functional nerve pathways.

  • How is the Salumedica Nerve Cuff supplied, and what sizes are available?

    The device is supplied sterile and pre-hydrated in saline to maintain its integrity. It comes in three inner diameter sizes: 2 mm, 5 mm, and 10 mm, allowing clinicians to select the appropriate size based on the nerve gap being treated.

  • Is the Salumedica Nerve Cuff intended for single-use or reusable applications?

    The Salumedica Nerve Cuff is explicitly designed for single-use applications in clinical settings. This ensures sterility and safety for each patient, reducing the risk of cross-contamination or degradation from repeated use.

  • What should be considered when storing the Salumedica Nerve Cuff?

    Since the device is supplied sterile and hydrated in saline, it should be stored in its original packaging under clean, dry conditions to preserve sterility and prevent contamination. Avoid exposure to extreme temperatures or direct sunlight, as these factors could compromise the integrity of the sheath.

  • Does the Salumedica Nerve Cuff have any specific regulatory approvals?

    The Salumedica Nerve Cuff has received FDA 510(k) clearance under regulation 882.5275, classifying it as a Class II medical device. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for nerve cuffs.