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FDA 510(k)

NIPLETTE

K-Number: K952035 · 1995-07-28

ApplicantAvent America, Inc.
Decision Date1995-07-28
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NIPLETTE is the device name listed in this FDA 510(k) record. The listed applicant is Avent America, Inc.. It received FDA 510(k) clearance on 1995-07-28 under 510(k) number K952035. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIPLETTE?

NIPLETTE is a medical device that received FDA 510(k) clearance on 1995-07-28. The listed applicant is Avent America, Inc.. The 510(k) number is K952035.

When did NIPLETTE receive FDA 510(k) clearance?

NIPLETTE received FDA 510(k) clearance on 1995-07-28, under 510(k) number K952035.

Who is the listed applicant for NIPLETTE?

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

What is the FDA product code for NIPLETTE?

The FDA product code for NIPLETTE is HGY.

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 Avent America, 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.

K052047ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101K051413ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100K944117AVENT NIPPLE SHIELD

Related Devices (Code: HGY)

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.

K101538HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK LimitedK032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK962828EVERT-ITGenesis Industries, 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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