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Orchid BP2703

by Quest USA Corp.

Orchid BP2703 is a Class II device made by Quest USA Corp., cleared under FDA 510(k) K231341 on 14 Aug 2023 and listed in FDA GUDID since 1 Mar 2024 (UDI-DI 00810146461463), 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) K231341

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 Number00810146461463 UDI-DI Date1 Mar 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 00810146461463 listed 1 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231341
  2. Listed FDA GUDID 00810146461463

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Orchid
Generic name
Menstrual tampon, unscented
Model / reference
BP2703
Primary DI / UDI-DI
00810146461463
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 Quest USA Corp.

See all devices from Quest USA Corp. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)