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)

BIOBRANE(R) II

K-Number: K896110 · 1989-11-28

ApplicantSterling Drug, Inc.
Decision Date1989-11-28
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

BIOBRANE(R) II is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Drug, Inc.. It received FDA 510(k) clearance on 1989-11-28 under 510(k) number K896110. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOBRANE(R) II?

BIOBRANE(R) II is a medical device that received FDA 510(k) clearance on 1989-11-28. The listed applicant is Sterling Drug, Inc.. The 510(k) number is K896110.

When did BIOBRANE(R) II receive FDA 510(k) clearance?

BIOBRANE(R) II received FDA 510(k) clearance on 1989-11-28, under 510(k) number K896110.

Who is the listed applicant for BIOBRANE(R) II?

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

What is the FDA product code for BIOBRANE(R) II?

The FDA product code for BIOBRANE(R) II is KGN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sterling Drug, 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.

K901369GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE IIK875275WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMERK840260PERIOGRAF DURAPATITE 40-60 MESHK820023CONAGRAF TM DURAPATITE CONESK820164EMPTY STERILE CARPUJECTK813257ALVEOGRAF DURAPATITE(18-40 MESH)

View all 9 devices →

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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.

↑