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POTENZA Tip A1-12

by Jeisys Medical Incorporated 2 variants

POTENZA Tip A1-12 is a Class II device made by Jeisys Medical Incorporated, cleared under FDA 510(k) K231216 on 10 Dec 2024 (3 earlier submissions) and listed in FDA GUDID since 29 Mar 2022 (UDI-DI 08800020101136), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK231216 Date10 Dec 2024IssuedStatusActive
United StatesGUDID listing Number08800020101136 UDI-DI Date29 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231216 decided 10 Dec 2024 Active· +3 more in the status table
  • FDA GUDID UDI-DI 08800020101136 listed 29 Mar 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K192545
  2. Cleared FDA 510(k) K201685
  3. Listed FDA GUDID 08800020101136
  4. Cleared FDA 510(k) K231287
  5. Cleared FDA 510(k) K231216

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
POTENZA Tip
Generic name
Electrosurgical system
Model / reference
A1-12
Primary DI / UDI-DI
08800020101136
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrosurgical system

Cleared under the same submission (K192545)

and 8 more cleared under K192545

Cleared under the same submission (K201685)

and 8 more cleared under K201685

Similar devices in this category

Other devices filed under Electrosurgical system.

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
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)