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FDA 510(k)

SOFTCUP(TM):2

K-Number: K920792 · 1993-10-05

ApplicantUltrafem, Inc.
Decision Date1993-10-05
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOFTCUP(TM):2 is the device name listed in this FDA 510(k) record. The listed applicant is Ultrafem, Inc.. It received FDA 510(k) clearance on 1993-10-05 under 510(k) number K920792. 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 SOFTCUP(TM):2?

SOFTCUP(TM):2 is a medical device that received FDA 510(k) clearance on 1993-10-05. The listed applicant is Ultrafem, Inc.. The 510(k) number is K920792.

When did SOFTCUP(TM):2 receive FDA 510(k) clearance?

SOFTCUP(TM):2 received FDA 510(k) clearance on 1993-10-05, under 510(k) number K920792.

Who is the listed applicant for SOFTCUP(TM):2?

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

What is the FDA product code for SOFTCUP(TM):2?

The FDA product code for SOFTCUP(TM):2 is HHE.

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 Ultrafem, 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.

K971303INSTEAD, SOFTCUP

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.K112165RHEA CUPApex Medical Technologies, Inc.K092985BELLECUPLibrette, Inc.K091754LUNETTE MENSTRUAL CUP, MODELS 1 AND 2Lune Group , Ltd.

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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