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Ellipsys Power Controller AMI1001

by Ellipsys, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884400263711 UDI-DIDate10 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ellipsys Power Controller
Generic Name
Peripheral vascular electrocautery catheter, single-use
Model / Reference
AMI1001
Primary DI / UDI-DI
00884400263711
FDA Product Code
PQK
GMDN Term
Peripheral vascular electrocautery catheter, single-use
Device Class
Class II
Regulation Number
870.1252
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Ellipsys, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No