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FDA 510(k)

RHEA CUP

K-Number: K112165 · 2012-05-24

ApplicantApex Medical Technologies, Inc.
Decision Date2012-05-24
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RHEA CUP is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Technologies, Inc.. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K112165. The device is classified under product code HHE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHEA CUP?

RHEA CUP is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Apex Medical Technologies, Inc.. The 510(k) number is K112165.

When did RHEA CUP receive FDA 510(k) clearance?

RHEA CUP received FDA 510(k) clearance on 2012-05-24, under 510(k) number K112165.

Who is the listed applicant for RHEA CUP?

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

What is the FDA product code for RHEA CUP?

The FDA product code for RHEA CUP is HHE.

Other records listing Apex Medical Technologies, 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.

K060933SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEMK954791SEMINAL FLUID COLLECTION KIT IIK922688EXTRA PROTECTION POLYURETHANE CONDOMK930313APEX SPECIMEN BAGK902936POLYURETHANE CONDOMK871358SENSATIONS BRAND CONDOMS

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Related Devices (Code: HHE)

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.

K233361Sunny Cup and ApplicatorMenstrual MatesK121857FEMMYCYCLEFemcap IncorporatedK120107SCKOONCUPSckoon, Inc.K092985BELLECUPLibrette, Inc.K091754LUNETTE MENSTRUAL CUP, MODELS 1 AND 2Lune Group , Ltd.K070965ALICIA MENSTRUAL CUPAlicia International Pty , Ltd.

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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