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)

SURGISIS

K-Number: K980431 · 1998-05-28

ApplicantCook Biotech, Inc.
Decision Date1998-05-28
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISIS is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 1998-05-28 under 510(k) number K980431. 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 SURGISIS?

SURGISIS is a medical device that received FDA 510(k) clearance on 1998-05-28. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K980431.

When did SURGISIS receive FDA 510(k) clearance?

SURGISIS received FDA 510(k) clearance on 1998-05-28, under 510(k) number K980431.

Who is the listed applicant for SURGISIS?

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

What is the FDA product code for SURGISIS?

The FDA product code for SURGISIS 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 Cook Biotech, 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.

K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTK111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIX

View all 29 devices →

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.

↑