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Pps Pi U201910

by Perouse Medical

Pps Pi U201910 is a Class II device made by Perouse Medical, cleared under FDA 510(k) K120261 on 2 May 2012 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 03661234011193), 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) K120261

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 Number03661234011193 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120261 Date2 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120261 decided 2 May 2012 Active
  • FDA GUDID UDI-DI 03661234011193 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120261
  2. Listed FDA GUDID 03661234011193

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pps Pi
Generic name
Subcutaneous infusion/injection port needle
Model / reference
U201910
Primary DI / UDI-DI
03661234011193
510(k) Number
FDA product code
FMI
GMDN term
Subcutaneous infusion/injection port needle
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Subcutaneous infusion/injection port needle

Cleared under the same submission (K120261)

and 8 more cleared under K120261

Similar devices

Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).

Other devices from Perouse Medical

See all devices from Perouse Medical →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)