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Device Explorer · FDA GUDID · GMDN 41978

Surgical irrigation/aspiration system

An assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping

US‑registered devices66in commercial distribution
Companies6labelers on GUDID
Single‑use48%of device records
Sterile35%labelled sterile
Prescription61%Rx‑only share
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Share of device records

Penumbra, Inc.3452%
Surgical Direct, Inc.1929%
Karl Storz Gmbh & Co. Kg46%
Lucas Medical Inc46%
Taiwan Biomaterial Company Limited35%
Promepla23%

Top labelers

CompanyDevicesShare
Penumbra, Inc.3452%
Surgical Direct, Inc.1929%
Karl Storz Gmbh & Co. Kg46%
Lucas Medical Inc46%
Taiwan Biomaterial Company Limited35%
Promepla23%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ZOOM Aspiration Pumpn.a.ROCAFLOW Irrigation, Warming and Suction SystemRocaFlow Irrigation warming SystemIndigo SystemPenumbra SystemIndigo Aspiration SystemArtemisApollo SystemSurgical DirectLMI IRRIGATION (STRAIGHT) CATHETER

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered19
GBXCATHETER, IRRIGATION17
GWGEndoscope, Neurological9
JCXAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED8
GWGENDOSCOPE, NEUROLOGICAL8
DXECatheter, Embolectomy6

GMDN & GCC registration

  • GMDN code 41978 · non‑implantable
  • Single‑use 48% · sterile 35% · Rx‑only 61% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 17Length (Centimeter) · 11

Use these as the dimensions to specify in a tender line.

How many surgical irrigation/aspiration system products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical irrigation/aspiration system", from 6 companies. The largest labeler is Penumbra, Inc. with 52% of records.

Which FDA product codes apply?

GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), GBX (CATHETER, IRRIGATION), GWG (Endoscope, Neurological), JCX (APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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