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JADA System 500063

by GI Supply, Inc.

JADA System 500063 is a Class II device made by GI Supply, Inc., cleared under FDA 510(k) K253642 on 15 May 2026 and listed in FDA GUDID since 17 Jul 2026 (UDI-DI 00893029002854), 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) K253642

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 Number00893029002854 UDI-DI Date17 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK253642 Date15 May 2026IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253642 decided 15 May 2026 Active
  • FDA GUDID UDI-DI 00893029002854 listed 17 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253642
  2. Listed FDA GUDID 00893029002854

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
JADA System
Generic name
Intrauterine haemostatic suction catheter
Model / reference
500063
Primary DI / UDI-DI
00893029002854
510(k) Number
FDA product code
OQY
GMDN term
Intrauterine haemostatic suction catheter
Device class
Class II
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253642)

and 2 more cleared under K253642

Other devices from GI Supply, Inc.

See all devices from GI Supply, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)