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PANPAC MEDICAL CORPORATION · Model M0016 · UDI-DI 04715309125014

HHK Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette 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2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a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.