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)

BENCOX FORET & BENCOX DELTA

K-Number: K121665 · 2012-09-25

Decision Date2012-09-25
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BENCOX FORET & BENCOX DELTA is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2012-09-25 under 510(k) number K121665. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENCOX FORET & BENCOX DELTA?

BENCOX FORET & BENCOX DELTA is a medical device that received FDA 510(k) clearance on 2012-09-25. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K121665.

When did BENCOX FORET & BENCOX DELTA receive FDA 510(k) clearance?

BENCOX FORET & BENCOX DELTA received FDA 510(k) clearance on 2012-09-25, under 510(k) number K121665.

Who is the listed applicant for BENCOX FORET & BENCOX DELTA?

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

What is the FDA product code for BENCOX FORET & BENCOX DELTA?

The FDA product code for BENCOX FORET & BENCOX DELTA is LZO.

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 Corentec Co., Ltd. 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 31 devices →

Related Devices (Code: LZO)

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.

↑