LP Coil System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LP Detachment Handle EUDAMEDLP Coil System FDA UDI
- Generic Name
- Non-neurovascular embolization coil FDA UDI
- Device Name
- Detachment Handle EUDAMEDLP Detachment Handle FDA UDI
- Model / Reference
- RLPH1 EUDAMEDFDA UDILP Detachment Handle EUDAMED
- Description
- LP Detachment Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810169721193 EUDAMED00815948021969 FDA UDI
- Basic UDI-DI
- 081454801RLPH18T EUDAMED
- 510(k) Number
- K192955 FDA UDI
- FDA Product Code
- HCG FDA UDI
- EMDN Code
- C010402020301 EMBOLISATION COILS EUDAMED
- GMDN Term
- Non-neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Neurovascular embolization coilNon-neurovascular embolization coil
LP Coil System by Penumbra, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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:
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
- LP Coil System — PENUMBRA, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA UDI 205b1077-59ec-4da0-8f81-4cbde60e641b 34 fields · synced Jun 18, 2026
- EUDAMED 1791c9c4-4b78-4d73-ab89-ba2e89d3d47f 61 fields · synced Jun 18, 2026