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FDA 510(k)

MARINA MEDICAL SILICONE PESSARY

K-Number: K031463 · 2003-11-18

ApplicantMarina Medical Instruments, Inc.
Decision Date2003-11-18
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MARINA MEDICAL SILICONE PESSARY is the device name listed in this FDA 510(k) record. The listed applicant is Marina Medical Instruments, Inc.. It received FDA 510(k) clearance on 2003-11-18 under 510(k) number K031463. 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 MARINA MEDICAL SILICONE PESSARY?

MARINA MEDICAL SILICONE PESSARY is a medical device that received FDA 510(k) clearance on 2003-11-18. The listed applicant is Marina Medical Instruments, Inc.. The 510(k) number is K031463.

When did MARINA MEDICAL SILICONE PESSARY receive FDA 510(k) clearance?

MARINA MEDICAL SILICONE PESSARY received FDA 510(k) clearance on 2003-11-18, under 510(k) number K031463.

Who is the listed applicant for MARINA MEDICAL SILICONE PESSARY?

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

What is the FDA product code for MARINA MEDICAL SILICONE PESSARY?

The FDA product code for MARINA MEDICAL SILICONE 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 Marina Medical Instruments, 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.

K042534MARINA MEDICAL FINGER PROTECTORSK021876MAS WITH OR WITHOUT SYRINGEK023725HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247K010296UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

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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