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FDA 510(k)

MODIFICATION TO URESTA PESSARY

K-Number: K083769 · 2009-01-14

ApplicantEastmed, Inc.
Decision Date2009-01-14
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2009-01-14 under 510(k) number K083769. 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 MODIFICATION TO URESTA PESSARY?

MODIFICATION TO URESTA PESSARY is a medical device that received FDA 510(k) clearance on 2009-01-14. The listed applicant is Eastmed, Inc.. The 510(k) number is K083769.

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

MODIFICATION TO URESTA PESSARY received FDA 510(k) clearance on 2009-01-14, under 510(k) number K083769.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO URESTA PESSARY?

The FDA product code for MODIFICATION TO 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.

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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.

K081385URESTA 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

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

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