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Reia FP01-1

by Reia, LLC

Reia FP01-1 is a pelvic-organ-supporting pessary (FDA Class II; FDA product code HHW, Pessary, Vaginal) made by Reia, LLC, cleared under FDA 510(k) K232677 on 21 May 2024 and listed in FDA GUDID since 22 Jul 2024 (UDI-DI 00860012119332), 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) K232677

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 Number00860012119332 UDI-DI Date22 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232677 Date21 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232677 decided 21 May 2024 Active
  • FDA GUDID UDI-DI 00860012119332 listed 22 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232677
  2. Listed FDA GUDID 00860012119332

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reia
Generic name
Pelvic-organ-supporting pessary
Model / reference
FP01-1
Primary DI / UDI-DI
00860012119332
510(k) Number
FDA product code
HHW
GMDN term
Pelvic-organ-supporting pessary
Device class
Class II
Regulation number
884.3575
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pelvic-organ-supporting pessary

Cleared under the same submission (K232677)

and 2 more cleared under K232677

Similar devices

Other devices filed under FDA product code HHW (Pessary, Vaginal).

Other devices from Reia, LLC

  • Reia PP01-2

    Class II

  • Reia FP01-2

    Class II

  • Reia PP01-1

    Class II

  • Reia AA01-2

    Class I

See all devices from Reia, LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)