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Vapr 225002

by Medos International Sàrl

Vapr 225002 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K963783 on 25 Nov 1996 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10886705009053), 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) K963783

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 Number10886705009053 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK963783 Date25 Nov 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K963783 decided 25 Nov 1996 Active
  • FDA GUDID UDI-DI 10886705009053 listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K963783
  2. Listed FDA GUDID 10886705009053

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vapr
Generic name
Electrosurgical handpiece, reusable
Model / Ref / Catalog
225002
Primary DI / UDI-DI
10886705009053
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical handpiece, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under Electrosurgical handpiece, reusable.

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Properties

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