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SureTouch Mobile Pressure Mapping System 1885

by Sure Inc.

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 Number00860000501712 UDI-DI Date28 Oct 2021ListedStatusListed 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  • Withdrawn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
SureTouch Mobile Pressure Mapping System
Generic Name
Breast lesion examination system
Model / Reference
1885
Primary DI / UDI-DI
00860000501712
510(k) Number
FDA Product Code
NKA
GMDN Term
Breast lesion examination system
Device Class
Class II
Regulation Number
884.2990
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Electronic clinical breast examination system

Cleared under the same submission (K181672)

Other devices from Sure 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