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CrossGlide ETS

CROSS BAY MEDICAL, INC. · Model CBPN3001 · UDI-DI 00850012760054

HHK Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.

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2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a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.