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Speculum H57

by Cynosure, LLC

Speculum H57 is a Class I device made by Cynosure, LLC, listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00841494104672), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841494104672 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Speculum
Generic name
Vaginal speculum, reusable
Model / Ref / Catalog
H57
Primary DI / UDI-DI
00841494104672
FDA product code
HDF
GMDN term
Vaginal speculum, reusable
Device class
Class I
Regulation number
884.4520
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vaginal speculum, reusable

Other devices from Cynosure, LLC

See all devices from Cynosure, LLC →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)