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)

STRATASIS SLING KIT

K-Number: K020654 · 2002-04-09

ApplicantCook Biotech, Inc.
Decision Date2002-04-09
Product CodePAG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRATASIS SLING KIT 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 2002-04-09 under 510(k) number K020654. The device is classified under product code PAG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATASIS SLING KIT?

STRATASIS SLING KIT is a medical device that received FDA 510(k) clearance on 2002-04-09. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K020654.

When did STRATASIS SLING KIT receive FDA 510(k) clearance?

STRATASIS SLING KIT received FDA 510(k) clearance on 2002-04-09, under 510(k) number K020654.

Who is the listed applicant for STRATASIS SLING KIT?

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 STRATASIS SLING KIT?

The FDA product code for STRATASIS SLING KIT is PAG.

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: PAG)

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.

K090688COOK UROLOGICAL GRAFTCook Biotech, Inc.K050445AMS COLLAGEN DERMAL MATRIXAmerican Medical Systems, Inc.K042949PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)C.R. Bard, Inc.K031295BARD INNERLACE BIOURETHRAL SUPPORT SYSTEMC.R. Bard, Inc.K030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXBrennen Medical, Inc.K993459MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXAdvanced Uroscience, 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.

↑