CryoTreQ— 510(k) K202038

Substantially Equivalent

VitreQ BV

FDA 510(k) clearance K202038 for CryoTreQ, Substantially Equivalent on 2020-12-30. Applicant: VitreQ BV. Device class: 2.

Clearance details

Applicant: VitreQ BV
Product code: Code HPS
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 2020-07-23
Decision date: 2020-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vierpolders, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code HPS

K940373 — OPHTHALMIC CRYO UNIT1994-07-18
K923629 — OPHTHALMIC TRICHIASIS PROBE1992-10-19
K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES1990-10-11
K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNIT1988-01-29
K873388 — KEELER CTU CRYO SYSTEM1987-11-13

More clearances from VitreQ BV

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Recalls naming K202038

K-number listed on FDA's recall record

Z-1497-2023 — CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01Class II·Ongoing·Beaver Visitec International, Inc.·20230317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202038.

Data sourced from openFDA. This site is unofficial and independent of the FDA.