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StaClear Syringe

by Tribofilm Research, Inc.

510(k) K200242

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K200242↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK200242 Date27 Jul 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 · 510(k)

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

Overview

AI-generated summary, 18 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 StaClear Syringe is an Ophthalmic Syringe, designed for precise fluid administration in eye care procedures. Its transparent, non-reflective barrel allows for accurate visual assessment of medication volume and clarity, reducing the risk of contamination or misadministration during delicate ophthalmic applications.

This device is supplied as a single-use, sterile product and is intended for use in general hospital settings. It adheres to FDA 510(k) clearance under the General Hospital advisory committee classification, with a device class of II. Available in multiple registration numbers (e.g., 1064858, 3026478941), it complies with regulation number 880.5860 and is manufactured by Tribofilm Research, Inc. Proper storage and handling are critical to maintaining sterility and performance.

Other devices from Tribofilm Research, Inc.