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Pixie Cup B0GMTGNF1M

by Pixie Cup, LLC

Pixie Cup B0GMTGNF1M is a menstrual tampon (FDA Class II; FDA product code HEB, Tampon, Menstrual, Unscented) made by Pixie Cup, LLC, cleared under FDA 510(k) K251033 on 13 Aug 2025 and listed in FDA GUDID since 19 Mar 2026 (UDI-DI 00850068130924), 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) K251033

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 Number00850068130924 UDI-DI Date19 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK251033 Date13 Aug 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251033 decided 13 Aug 2025 Active
  • FDA GUDID UDI-DI 00850068130924 listed 19 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251033
  2. Listed FDA GUDID 00850068130924

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pixie Cup
Generic name
Menstrual tampon, unscented
Model / reference
B0GMTGNF1M
Primary DI / UDI-DI
00850068130924
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

Cleared under the same submission (K251033)

and 8 more cleared under K251033

Similar devices

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

Other devices from Pixie Cup, LLC

See all devices from Pixie Cup, LLC →

Properties

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