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FDA 510(k)

INSTEAD, SOFTCUP

K-Number: K971303 · 1997-06-06

ApplicantUltrafem, Inc.
Decision Date1997-06-06
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSTEAD, SOFTCUP is the device name listed in this FDA 510(k) record. The listed applicant is Ultrafem, Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K971303. 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 INSTEAD, SOFTCUP?

INSTEAD, SOFTCUP is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Ultrafem, Inc.. The 510(k) number is K971303.

When did INSTEAD, SOFTCUP receive FDA 510(k) clearance?

INSTEAD, SOFTCUP received FDA 510(k) clearance on 1997-06-06, under 510(k) number K971303.

Who is the listed applicant for INSTEAD, SOFTCUP?

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 INSTEAD, SOFTCUP?

The FDA product code for INSTEAD, SOFTCUP 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.

K920792SOFTCUP(TM):2

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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