FDA 510(k) clearance · back to tracker

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS

Cook Biotech Incorporated cleared K130006 on 2013-04-05, decision: substantially equivalent

K-number

K130006

Sponsor

Cook Biotech Incorporated

Device

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS

Class

Class III

Decision

Substantially Equivalent

Decision date

2013-04-05

Product code

PAI

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5980

Official FDA record

Open K130006on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K130006 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.