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Aptra BDCYSD01

by Otu Medical Inc.

Aptra BDCYSD01 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) and listed in FDA GUDID since 30 Sep 2024 (UDI-DI 00850023925381), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850023925381 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231702 Date29 Sep 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231702 decided 29 Sep 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850023925381 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 00850023925381

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aptra
Generic name
Flexible video cystoscope, single-use
Model / reference
BDCYSD01
Primary DI / UDI-DI
00850023925381
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)