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Speedboat UltraSlim Short PRD-SB1-002

by Creo Medical, Ltd. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number05060359561442 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Speedboat UltraSlim Short
Generic Name
Endoscopic electrosurgical/microwave submucosal lift/resection instrument
Model / Ref / Catalog
PRD-SB1-002
Primary DI / UDI-DI
05060359561442
510(k) Number
FDA Product Code
KNS
GMDN Term
Endoscopic electrosurgical/microwave submucosal lift/resection instrument
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 1.25 Meter
Outer Diameter — 2.4 Millimeter

Related devices

Cleared under the same submission (K230328)

Other devices from Creo Medical, Ltd.

See all devices from Creo Medical, Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No