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Suction jar 2L 4052usa

by Nouvag AG

Suction jar 2L 4052usa is a Class II device made by Nouvag AG, cleared under FDA 510(k) K042943 on 17 Dec 2004 and listed in FDA GUDID since 14 Dec 2021 (UDI-DI ENOU4052USA9), active as of 23 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 23 Oct 2026

Documents

510(k) K042943

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberENOU4052USA9 UDI-DI Date14 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042943 Date17 Dec 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042943 decided 17 Dec 2004 Active
  • FDA GUDID UDI-DI ENOU4052USA9 listed 14 Dec 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042943
  2. Listed FDA GUDID ENOU4052USA9

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Suction jar 2L
Generic name
Suction/irrigation system canister/bottle holder, single-use
Model / reference
4052usa
Primary DI / UDI-DI
ENOU4052USA9
510(k) Number
FDA product code
BTA
GMDN term
Suction/irrigation system canister/bottle holder, single-use
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Nouvag AG

See all devices from Nouvag AG →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)