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POTENZA Tip I-16

by Jeisys Medical Incorporated

Ref I-16Model I-16 TIP

POTENZA Tip I-16 is a device classified as Class IIb in the EU and Class II in the US made by Jeisys Medical Incorporated, registered in EUDAMED on 11 May 2026 (Basic UDI-DI B-08800020107527), cleared under FDA 510(k) K192545 on 20 Feb 2020 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 08800020107527), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192545

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800020107527 Basic UDI-DI 08800020107527UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800020107527 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192545 Date20 Feb 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800020107527 registered 11 May 2026 Active
  • FDA 510(k) K192545 decided 20 Feb 2020 Active
  • FDA GUDID UDI-DI 08800020107527 listed 27 Feb 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192545
  2. Listed FDA GUDID 08800020107527
  3. Registered EUDAMED B-08800020107527

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
I-16 Tip EUDAMED
POTENZA Tip GUDID
Generic name
Electrosurgical system
Model / reference
I-16, I-16 TIP
Primary DI / UDI-DI
08800020107527 EUDAMED
08800020111142 GUDID
Basic UDI-DI
B-08800020107527
510(k) Number
FDA product code
GEI
EMDN code
K020380 Devices for surgery with radiofrequency generator, single-use - accessories
GMDN term
Electrosurgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08800020107527
GUDID
08800020111142
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08800020107527; FDA GUDID lists 08800020111142), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrosurgical system

Cleared under the same submission (K192545)

and 8 more cleared under K192545

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES.

Other devices from Jeisys Medical Incorporated

  • INTRAcel Tip 3

    Class II

  • INTRAcel Tip 1010

    Class II

  • INTRAcel Tip 1012

    Class II

  • POTENZA Tip CP-21 TIP

    Class II

See all devices from Jeisys Medical Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)