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Bpure 64431638E

by Fourstar Group Inc.

Bpure 64431638E is a Class II device made by Fourstar Group Inc., cleared under FDA 510(k) K231341 on 14 Aug 2023 and listed in FDA GUDID since 10 Dec 2024 (UDI-DI 00049696608107), 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) K231341

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 Number00049696608107 UDI-DI Date10 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231341 Date14 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231341 decided 14 Aug 2023 Active
  • FDA GUDID UDI-DI 00049696608107 listed 10 Dec 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231341
  2. Listed FDA GUDID 00049696608107

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bpure
Generic name
Menstrual tampon, unscented
Model / reference
64431638E
Primary DI / UDI-DI
00049696608107
510(k) Number
FDA product code
HEB
GMDN term
Menstrual tampon, unscented
Device class
Class II
Regulation number
884.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Menstrual tampon, unscented

Cleared under the same submission (K231341)

Similar devices

Other devices filed under FDA product code HEB (Tampon, Menstrual, Unscented).

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

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