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EndoSerter-PL ES-PL

by CorneaGen

EndoSerter-PL ES-PL is a Class I device made by CorneaGen, cleared under FDA 510(k) K203586 on 2 Feb 2022 and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 00855934007485), 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

510(k) K203586

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855934007485 UDI-DI Date9 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203586 Date2 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203586 decided 2 Feb 2022 Active
  • FDA GUDID UDI-DI 00855934007485 listed 9 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203586
  2. Listed FDA GUDID 00855934007485

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EndoSerter-PL
Generic name
Donor cornea delivery set
Model / reference
ES-PL
Primary DI / UDI-DI
00855934007485
510(k) Number
FDA product code
OTZ
GMDN term
Donor cornea delivery set
Device class
Class I
Regulation number
886.4300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Donor cornea delivery set

Other devices from CorneaGen

See all devices from CorneaGen →

Properties

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