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FDA 510(k)

RESTORE (AKA RE/STOR)

K-Number: K983164 · 1999-03-05

ApplicantNebl, Inc.
Decision Date1999-03-05
Product CodeMNG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RESTORE (AKA RE/STOR) is the device name listed in this FDA 510(k) record. The listed applicant is Nebl, Inc.. It received FDA 510(k) clearance on 1999-03-05 under 510(k) number K983164. The device is classified under product code MNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTORE (AKA RE/STOR)?

RESTORE (AKA RE/STOR) is a medical device that received FDA 510(k) clearance on 1999-03-05. The listed applicant is Nebl, Inc.. The 510(k) number is K983164.

When did RESTORE (AKA RE/STOR) receive FDA 510(k) clearance?

RESTORE (AKA RE/STOR) received FDA 510(k) clearance on 1999-03-05, under 510(k) number K983164.

Who is the listed applicant for RESTORE (AKA RE/STOR)?

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

What is the FDA product code for RESTORE (AKA RE/STOR)?

The FDA product code for RESTORE (AKA RE/STOR) is MNG.

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 Nebl, 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.

K971359RESTORE (A.K.A. CAPSURE)K954959CAP-AID

Related Devices (Code: MNG)

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.

K010365ORTHO CONTROL FEMALE URINARY CONTROL DEVICEPersonal Products Co.K974600UROMED PATCHUromed Corp.K974645FEMASSIST FLEXIBLEInsight Medical Corp.K971359RESTORE (A.K.A. CAPSURE)Nebl, Inc.K963858FEMASSIST URINARY DEVICEInsight Medical Corp.K954215MINIGUARDAdvanced Surgical Intervention, 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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