BioZorb LP Marker

FDA 510(k) K152070 · Focal Therapeutics

Substantially Equivalent

510(k) numberK152070

Submission

Device name
BioZorb LP Marker
Applicant
Focal Therapeutics
Portola Valley, CA, US
Received
July 27, 2015
Decision date
August 26, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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More from Molli Surgical, Inc.

510(k)DeviceDecision
K192371BioZorb SP MarkerNEU · Special 09/26/2019SE
K171467BioZorb Marker GOLD / LP Marker GOLDIYE · Traditional 11/09/2017SE
K143484BioZorb MarkerNEU · Traditional 06/29/2015SE
K113202Tissue MarkerNEU · Traditional 02/28/2012SE

Questions and answers

When was BioZorb LP Marker cleared by the FDA?

BioZorb LP Marker (K152070) received a 510(k) decision of Substantially Equivalent on August 26, 2015, 30 days after the submission was received.

What is the product code of K152070?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.