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FDA 510(k)

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS

K-Number: K130006 · 2013-04-05

ApplicantCook Biotech Incorporated
Decision Date2013-04-05
Product CodePAI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K130006. The device is classified under product code PAI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS?

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K130006.

When did BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS receive FDA 510(k) clearance?

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS received FDA 510(k) clearance on 2013-04-05, under 510(k) number K130006.

Who is the listed applicant for BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS?

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

What is the FDA product code for BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS?

The FDA product code for BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS is PAI.

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Other records listing Cook Biotech Incorporated as applicant

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Related Devices (Code: PAI)

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.

K050355PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150Tissue Science Laboratories, Plc

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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