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)

PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

K-Number: K043388 · 2005-08-05

ApplicantPegasus Biologics, Inc.
Decision Date2005-08-05
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Biologics, Inc.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K043388. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH?

PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Pegasus Biologics, Inc.. The 510(k) number is K043388.

When did PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH receive FDA 510(k) clearance?

PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH received FDA 510(k) clearance on 2005-08-05, under 510(k) number K043388.

Who is the listed applicant for PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH?

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

What is the FDA product code for PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH?

The FDA product code for PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH is FTM.

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 Pegasus Biologics, 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.

K090288ORTHADAPT PRK071425UNITE BIOMATRIXK071065ORTHADAPT BIOIMPLANTK061494DERMADAPT WOUND DRESSING

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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.

↑