Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MACROPORE IB RESORBABLE PLUG

K-Number: K011715 · 2001-08-27

Decision Date2001-08-27
Product CodeJDI
Advisory CommitteeOR
DecisionUnknown

Device Summary

MACROPORE IB RESORBABLE PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Macropore Biosurgery, Inc.. It received FDA 510(k) clearance on 2001-08-27 under 510(k) number K011715. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MACROPORE IB RESORBABLE PLUG?

MACROPORE IB RESORBABLE PLUG is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K011715.

When did MACROPORE IB RESORBABLE PLUG receive FDA 510(k) clearance?

MACROPORE IB RESORBABLE PLUG received FDA 510(k) clearance on 2001-08-27, under 510(k) number K011715.

Who is the listed applicant for MACROPORE IB RESORBABLE PLUG?

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

What is the FDA product code for MACROPORE IB RESORBABLE PLUG?

The FDA product code for MACROPORE IB RESORBABLE PLUG is JDI.

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.

Other records listing Macropore Biosurgery, 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.

View all 17 devices →

Related Devices (Code: JDI)

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.

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.

↑