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Aptra BDCYRD01

by Otu Medical Inc.

Aptra BDCYRD01 is a flexible video cystoscope (FDA Class II; FDA product code FAJ, Cystoscope And Accessories, Flexible/Rigid) made by Otu Medical Inc., cleared under FDA 510(k) K231702 on 29 Sep 2023 (1 earlier submission), registered in EUDAMED and listed in FDA GUDID since 30 Sep 2024 (UDI-DI 00850023925398), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231702

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850023925398 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231702 Date29 Sep 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K231702 decided 29 Sep 2023 Active· +1 more in the status table
  • EUDAMED Active
  • FDA GUDID UDI-DI 00850023925398 listed 30 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212202
  2. Cleared FDA 510(k) K231702
  3. Listed FDA GUDID 00850023925398

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Aptra
Generic name
Flexible video cystoscope, single-use
Model / reference
BDCYRD01
Primary DI / UDI-DI
00850023925398
510(k) Number
FDA product code
FAJ
GMDN term
Flexible video cystoscope, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video cystoscope, single-use

Cleared under the same submission (K212202)

Cleared under the same submission (K231702)

and 4 more cleared under K231702

Similar devices in this category

Other devices filed under Flexible video cystoscope, single-use.

Other devices from Otu Medical Inc.

  • Aptra

    Class IIa

  • WiScope® OTU-T Pro

    Class II

  • WiScope® OTU-140S

    Class II

  • WiScope® OTU-110R

    Class II

See all devices from Otu Medical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)