Penumbra System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref PAPS2Model Non-Sterile Pump MAX Supplies – Penumbra System

by Penumbra, Inc.

Identity

Trade Name: Non-Sterile Pump MAX Supplies – Penumbra System EUDAMED
Penumbra System FDA UDI
Generic Name: Surgical irrigation/aspiration system FDA UDI
Device Name: Pump MAX Canister EUDAMED
PS Pump Canister Kit FDA UDI
Model / Reference: PAPS2 EUDAMEDFDA UDI
Non-Sterile Pump MAX Supplies – Penumbra System EUDAMED
Description: PS Pump Canister Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00810169721827 EUDAMED
00814548012384 FDA UDI
Basic UDI-DI: 081454801PSSUPD8 EUDAMED
510(k) Number: K051758 FDA UDI
FDA Product Code: JCX FDA UDI
EMDN Code: A060199 SURGICAL DRAINAGE SYSTEMS - OTHER EUDAMED
GMDN Term: Surgical irrigation/aspiration system FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 878.4780 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical irrigation/aspiration system

Penumbra System by Penumbra, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration system.

Surgical Direct — SURGICAL DIRECT, INC. · Class II
ZOOM Aspiration Pump — Taiwan Biomaterial Co., Ltd. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
LMI IRRIGATION (STRAIGHT) CATHETER — LUCAS MEDICAL INC · Class II
LMI IRRIGATION (STRAIGHT) CATHETER — LUCAS MEDICAL INC · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
ROCAFLOW Irrigation, Warming and Suction System — Promepla · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II

Cleared under the same submission

K051758 also covers:

Penumbra System — PENUMBRA, INC.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

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

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Manufacturer

Manufacturer: Penumbra, Inc.

Sources (2)

FDA UDI ad3cf3c7-cfce-493c-b0ab-c636255cb4f9 34 fields · synced Jun 11, 2026
EUDAMED 5ea5b4e9-f817-4078-b206-324901427e88 61 fields · synced Jun 11, 2026