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ClearSpec 102

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 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 Number00860008900302 UDI-DI Date29 Oct 2025ListedStatusListed 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  • Withdrawn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
ClearSpec
Generic Name
Vaginal speculum, single-use
Model / Ref / Catalog
102
Primary DI / UDI-DI
00860008900302
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

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Properties

  • Single Use
  • Contains Latex
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: 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