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Konmed Km-5013

by Shenzhen Konmed Technology Co., Ltd.

Konmed Km-5013 is a Class II device made by Shenzhen Konmed Technology Co., Ltd., cleared under FDA 510(k) K233576 on 23 Feb 2024 and listed in FDA GUDID since 5 Mar 2024 (UDI-DI 06970935830680), 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) K233576

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 Number06970935830680 UDI-DI Date5 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233576 Date23 Feb 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233576 decided 23 Feb 2024 Active
  • FDA GUDID UDI-DI 06970935830680 listed 5 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233576
  2. Listed FDA GUDID 06970935830680

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Konmed
Generic name
Perineal orifice incontinence-control electrical stimulation system probe, reusable
Model / reference
KM-5013
Primary DI / UDI-DI
06970935830680
510(k) Number
FDA product code
KPI
GMDN term
Perineal orifice incontinence-control electrical stimulation system probe, reusable
Device class
Class II
Regulation number
876.5320
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Perineal orifice incontinence-control electrical stimulation system probe, reusable

Cleared under the same submission (K233576)

and 2 more cleared under K233576

Similar devices

Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Other devices from Shenzhen Konmed Technology Co., Ltd.

See all devices from Shenzhen Konmed Technology Co., Ltd. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)