LP Coil System

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name: LP Coil System FDA UDI
Generic Name: Non-neurovascular embolization coil FDA UDI
Device Name: Ruby Coil LP, 5 mm x 30 cm FDA UDI
Model / Reference: RBYLP0530 FDA UDI
Description: Ruby Coil LP, 5 mm x 30 cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00815948021846 FDA UDI
510(k) Number: K192955 FDA UDI
FDA Product Code: HCG FDA UDI
GMDN Term: Non-neurovascular embolization coil FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5950 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Neurovascular embolization coil Non-neurovascular embolization coil

The LP Coil System is a non-bioabsorbable, implantable device designed to treat intracranial aneurysms and neurovascular arteriovenous malformations (AVMs) with a unique, metal/synthetic polymer wire coil. This device is intended for use in the form of a pre-attached delivery wire, making it ideal for disposable or non-disposable implantation.

Similar devices

Also classified as Non-neurovascular embolization coil.

ConcertoTM — Micro Therapeutics, Inc. · Class II
Target — Stryker Corp. · Class II
Prestige Coil System — BALT USA LLC · Class II
Optima Coil System — BALT USA LLC · Class II
Nester — COOK INCORPORATED · Class II
ConcertoTM — Micro Therapeutics, Inc. · Class II
TARGET — Stryker Corp. · Class II
GDC-10 — Stryker Corp. · Class II

Cleared under the same submission

K192955 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Penumbra, Inc.

Sources (1)

FDA UDI 68939401-07dc-451c-9a85-28442e41a9ce 34 fields · synced Jul 15, 2026