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Orbit Subretinal Delivery System

by Orbit Biomedical 2 variants

510(k) K200325

Active United States

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200325 Date14 Jul 2020ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orbit Subretinal Delivery System is a manual ophthalmic surgical instrument used for subretinal microinjections. It consists of a Subretinal Injection Device set, a Tubing Set, and a Dosing Set. The system features a flexible ophthalmic cannula with an advanceable needle and an internal mechanism. It is indicated for microinjection into the subretinal space.

The Orbit Subretinal Delivery System is supplied with various components and is used in a hospital setting. The device has been cleared under FDA 510K, with the reference number K200325. The system is designed to meet applicable standards and serves the same physiological purpose as a reference device. It is manufactured by Orbit Biomedical.

Other devices from Orbit Biomedical