Skip to content

Sphincterotome / short-wire compatible RDSP-0230-231-2

by Micro-Tech (Nanjing) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06932503516563 UDI-DI Date27 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sphincterotome / short-wire compatible
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Model / Reference
RDSP-0230-231-2
Primary DI / UDI-DI
06932503516563
510(k) Number
FDA Product Code
KNS
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution
Size
Atherectomy Device Tip Length — 2 Millimeter
Atherectomy Cutter Length — 30 Millimeter

Related devices

Cleared under the same submission (K210934)

Show all (12)

Other devices from Micro-Tech (Nanjing) Co., Ltd.

See all devices from Micro-Tech (Nanjing) Co., Ltd. →

Properties

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

Other properties (8)

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