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ClearSpec 104

by Clearspec, LLC 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 Number10860008900323 UDI-DI Date29 Oct 2025ListedStatusListed 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  • Withdrawn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
ClearSpec
Generic Name
Vaginal speculum, single-use
Model / Ref / Catalog
104
Primary DI / UDI-DI
10860008900323
510(k) Number
FDA Product Code
HIB
GMDN Term
Vaginal speculum, single-use
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K130046)

Show all (12)

Other devices from Clearspec, LLC

See all devices from Clearspec, LLC →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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