FDA 510(k)

MediClear PreOp

K-Number: K163556 · 2017-09-14

Decision Date2017-09-14

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MediClear PreOp is the device name listed in this FDA 510(k) record. The listed applicant is Covalontechnologies, Inc.. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K163556. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MediClear PreOp?

MediClear PreOp is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Covalontechnologies, Inc.. The 510(k) number is K163556.

When did MediClear PreOp receive FDA 510(k) clearance?

MediClear PreOp received FDA 510(k) clearance on 2017-09-14, under 510(k) number K163556.

Who is the listed applicant for MediClear PreOp?

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

What is the FDA product code for MediClear PreOp?

The FDA product code for MediClear PreOp is KKX.

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad Sterile CoverControlrad, 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.