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FDA 510(k)

URESTA PESSARY

K-Number: K081385 · 2008-10-09

ApplicantEastmed, Inc.
Decision Date2008-10-09
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

URESTA PESSARY is the device name listed in this FDA 510(k) record. The listed applicant is Eastmed, Inc.. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K081385. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESTA PESSARY?

URESTA PESSARY is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Eastmed, Inc.. The 510(k) number is K081385.

When did URESTA PESSARY receive FDA 510(k) clearance?

URESTA PESSARY received FDA 510(k) clearance on 2008-10-09, under 510(k) number K081385.

Who is the listed applicant for URESTA PESSARY?

The FDA 510(k) record lists Eastmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URESTA PESSARY?

The FDA product code for URESTA PESSARY is HHW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Eastmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083769MODIFICATION TO URESTA PESSARY

Related Devices (Code: HHW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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