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PANPAC MEDICAL CORPORATION · Model RD003 · UDI-DI 04715309124994

HHK Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The ETO Sterilized Curette is used to obtain a sample of differentiated endometrial tissue. The Curette is a 3mm (O.D.) endometrial suction curette with a Randall-like cutting edge at its distal end and packaged with a twist-and-lock syringe. The syringe provides the vacuum or suction during the procedure. The Curette is sterile unless the package is opened or damaged. It is designed for single patient use only.

Recalls

Date	Firm	Reason
2022-09-16	Olympus Corporation of the Americas	Update 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
2014-10-27	CooperSurgical, Inc.	The product has been identified to contain an incorrect curette type.
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a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.