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C Scope Visualization System

by Cit Ortho

510(k) K203526

C Scope Visualization System is a Class II device made by Cit Ortho, cleared under FDA 510(k) K203526 on 12 Jan 2021, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203526 Date12 Jan 2021ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1453-2025 FDA Class II initiated 11 Feb 2025

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

    • Ongoing Z-3053-2024 FDA Class II initiated 8 Apr 2024

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Timeline

3 dated events

  1. Cleared FDA 510(k) K203526
  2. Recall initiated FDA recalls Z-3053-2024
  3. Recall initiated FDA recalls Z-1453-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K203526

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K203526
UDI-DISize and differences
CIT Ortho 613034700
Cit Ortho
61303470020850009724001
Single use: yes
On the market
CIT Ortho 613034705
Cit Ortho
61303470500850009724021
Single use: no
On the market
CIT Ortho 613034706
Cit Ortho
61303470600850009724038
Single use: no
On the market

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Cit Ortho

See all devices from Cit Ortho →