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FDA 510(k)

SURGISIS SLING

K-Number: K992159 · 1999-09-23

ApplicantCook Biotech, Inc.
Decision Date1999-09-23
Product CodePAG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISIS SLING 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 1999-09-23 under 510(k) number K992159. 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 SURGISIS SLING?

SURGISIS SLING is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K992159.

When did SURGISIS SLING receive FDA 510(k) clearance?

SURGISIS SLING received FDA 510(k) clearance on 1999-09-23, under 510(k) number K992159.

Who is the listed applicant for SURGISIS SLING?

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 SLING?

The FDA product code for SURGISIS SLING is PAG.

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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

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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.K020654STRATASIS SLING KITCook Biotech, 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.

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