FDA 510(k)

KidCap

K-Number: K180568 · 2018-10-16

ApplicantEastern Cranial Affiliates, LLC

Decision Date2018-10-16

Product CodeMVA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

KidCap is the device name listed in this FDA 510(k) record. The listed applicant is Eastern Cranial Affiliates, LLC. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K180568. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KidCap?

KidCap is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Eastern Cranial Affiliates, LLC. The 510(k) number is K180568.

When did KidCap receive FDA 510(k) clearance?

KidCap received FDA 510(k) clearance on 2018-10-16, under 510(k) number K180568.

Who is the listed applicant for KidCap?

The FDA 510(k) record lists Eastern Cranial Affiliates, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KidCap?

The FDA product code for KidCap is MVA.

Related Devices (Code: MVA)

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.

K241957Talee, Talee PostOpInvent Medical USA, LLC K230444Talee, Talee PostOpInvent Medical USA, LLC K223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLC K203134Hanger Cranial Band 3DSymbion Logistics, LLC K213587MyCRO BandOtto Bock Healthcare LP

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.