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Amielle SM 2103

by Owen Mumford USA Incorporated

Amielle SM 2103 is a Class II device made by Owen Mumford USA Incorporated, cleared under FDA 510(k) K983045 on 25 Nov 1998 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00384702103017), 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) K983045

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 Number00384702103017 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983045 Date25 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983045 decided 25 Nov 1998 Active
  • FDA GUDID UDI-DI 00384702103017 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983045
  2. Listed FDA GUDID 00384702103017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Amielle
Generic name
Vaginal dilator
Model / reference
SM 2103
Primary DI / UDI-DI
00384702103017
510(k) Number
FDA product code
KXP
GMDN term
Vaginal dilator
Device class
Class II
Regulation number
884.3900
GUDID distribution status
In Commercial Distribution
Size
Length — 109 Millimeter

Related devices

Category: Vaginal dilator

Cleared under the same submission (K983045)

and 7 more cleared under K983045

Other devices from Owen Mumford USA Incorporated

See all devices from Owen Mumford USA Incorporated →

Properties

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