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Indigo Aspiration System IAPS3-A

by Penumbra, Inc.

Indigo Aspiration System IAPS3-A is a surgical irrigation/aspiration system (FDA Class II; FDA product code DXE, Catheter, Embolectomy) made by Penumbra, Inc., cleared under FDA 510(k) K180105 on 8 Mar 2018 and listed in FDA GUDID since 8 Oct 2018 (UDI-DI 00814548019703), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K180105

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814548019703 UDI-DI Date8 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK180105 Date8 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180105 decided 8 Mar 2018 Active
  • FDA GUDID UDI-DI 00814548019703 listed 8 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180105
  2. Listed FDA GUDID 00814548019703

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Indigo Aspiration System
Generic name
Surgical irrigation/aspiration system
Model / reference
IAPS3-A
Primary DI / UDI-DI
00814548019703
510(k) Number
FDA product code
DXE
GMDN term
Surgical irrigation/aspiration system
Device class
Class II
Regulation number
870.5150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation/aspiration system

Cleared under the same submission (K180105)

Similar devices

Other devices filed under FDA product code DXE (Catheter, Embolectomy).

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)