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Vacurette

Gyrus ACMI, LLC · Model 003696 · UDI-DI 00821925000025

HHK Prescription
10
510(k) clearances
60
Adverse events (1 deaths)
3
Recalls
49
Facilities

Description

Adapter, 14 mm Vacurette

Recalls

DateFirmReason
2022-09-16Olympus Corporation of the AmericasUpdate to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events inv
2014-10-27CooperSurgical, Inc.The product has been identified to contain an incorrect curette type.
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.