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Penumbra System PST1

by Penumbra, Inc.

Penumbra System PST1 is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K151623 on 6 Aug 2015 and listed in FDA GUDID since 30 Jul 2016 (UDI-DI 00814548010397), 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) K151623

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 Number00814548010397 UDI-DI Date30 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK151623 Date6 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151623 decided 6 Aug 2015 Active
  • FDA GUDID UDI-DI 00814548010397 listed 30 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151623
  2. Listed FDA GUDID 00814548010397

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Penumbra System
Generic name
Surgical irrigation/aspiration system
Model / reference
PST1
Primary DI / UDI-DI
00814548010397
510(k) Number
FDA product code
NRY
GMDN term
Surgical irrigation/aspiration system
Device class
Class II
Regulation number
870.1250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation/aspiration system

Cleared under the same submission (K151623)

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (10, all answered No)