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SandShark Injectable Anchor System

FDA UDI

Class II (US FDA UDI)

by Stimwave Technologies Incorporated

Identity

Trade Name
SandShark Injectable Anchor System FDA UDI
Generic Name
Analgesic spinal cord electrical stimulation system FDA UDI
Device Name
SandShark Injectable Anchor System FDA UDI
Model / Reference
SHRK-ALL-1K FDA UDI
Description
SandShark Injectable Anchor System FDA UDI

Identifiers

Primary DI / UDI-DI
00859619004202 FDA UDI
510(k) Number
K172644 FDA UDI
FDA Product Code
GZB FDA UDI
GMDN Term
Analgesic spinal cord electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Weight — 0.25 Gram FDA UDI

Category: Analgesic spinal cord electrical stimulation system

SandShark Injectable Anchor System by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic spinal cord electrical stimulation system.

Cleared under the same submission

K172644 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stimwave Technologies Incorporated

Sources (1)

  • FDA UDI 81778b87-f36e-47d8-90ce-31c37860071a 36 fields · synced Jun 6, 2026