FDA 510(k)

ANSiStim-PP

K-Number: K220397 · 2022-05-12

Decision Date2022-05-12

Product CodeNHI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ANSiStim-PP is the device name listed in this FDA 510(k) record. The listed applicant is Dyansys, Inc.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K220397. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSiStim-PP?

ANSiStim-PP is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Dyansys, Inc.. The 510(k) number is K220397.

When did ANSiStim-PP receive FDA 510(k) clearance?

ANSiStim-PP received FDA 510(k) clearance on 2022-05-12, under 510(k) number K220397.

Who is the listed applicant for ANSiStim-PP?

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

What is the FDA product code for ANSiStim-PP?

The FDA product code for ANSiStim-PP is NHI.

Other records listing Dyansys, 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.

K221425Primary Relief K221231Drug Relief v1 K213188Primary Relief K212859First Relief K211971Drug Relief v1 K202940First Relief v1

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Related Devices (Code: NHI)

K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.K221425Primary ReliefDyansys, Inc.K213188Primary ReliefDyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT PNS SystemSpr Therapeutics, Inc.K202660SPRINT PNS SystemSpr Therapeutics, 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.