Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cook Biotech, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
268 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133306 | SIS HERNIA GRAFT | Cook Biotech, Inc. | 2014-07-23 | 268 | 0 |
| K133011 | DIAPHRAGMATIC HERNIA GRAFT | Cook Biotech, Inc. | 2014-06-20 | 268 | 1 |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | Cook Biotech, Inc. | 2013-10-08 | 180 | 0 |
| K111695 | HYBRID GRAFT | Cook Biotech, Inc. | 2012-04-02 | 291 | 0 |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | Cook Biotech, Inc. | 2011-06-20 | 129 | 0 |
| K090688 | COOK UROLOGICAL GRAFT | Cook Biotech, Inc. | 2009-07-10 | 116 | 0 |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | Cook Biotech, Inc. | 2009-02-27 | 165 | 0 |
| K082058 | DYNAMATRIX | Cook Biotech, Inc. | 2008-10-02 | 73 | 0 |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | Cook Biotech, Inc. | 2008-03-21 | 109 | 0 |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | 2007-10-17 | 247 | 0 |
| K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | Cook Biotech, Inc. | 2007-04-05 | 20 | 0 |
| K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT | Cook Biotech, Inc. | 2006-10-13 | 32 | 0 |
| K062696 | SURGISIS, SURGISIS ES | Cook Biotech, Inc. | 2006-10-13 | 32 | 0 |
| K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | Cook Biotech, Inc. | 2006-10-10 | 27 | 12 |
| K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | Cook Biotech, Inc. | 2006-10-02 | 54 | 0 |
| K061711 | OASIS WOUND MATRIX | Cook Biotech, Inc. | 2006-07-19 | 30 | 0 |
| K051048 | SURGISIS STAPLE LINE REINFORCEMENT II | Cook Biotech, Inc. | 2005-09-23 | 151 | 0 |
| K050246 | SIS DERMAL AUGMENTATION STRAND | Cook Biotech, Inc. | 2005-05-19 | 106 | 0 |
| K050337 | SIS FISTULA PLUG | Cook Biotech, Inc. | 2005-03-09 | 27 | 0 |
| K034039 | SIS PLASTIC SURGERY MATRIX | Cook Biotech, Inc. | 2004-02-18 | 51 | 0 |
| K031850 | DURASIS DURAL SUBSTITUTE | Cook Biotech, Inc. | 2003-09-08 | 84 | 0 |
| K031069 | SURGISIS NERVE CUFF | Cook Biotech, Inc. | 2003-05-15 | 41 | 0 |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | 2002-08-23 | 60 | 0 |
| K010952 | SURGISIS GUIDED TISSUE REGENERATION MATRIX | Cook Biotech, Inc. | 2002-06-10 | 437 | 0 |
| K020732 | SS MATRIX | Cook Biotech, Inc. | 2002-05-30 | 85 | 0 |
| K020654 | STRATASIS SLING KIT | Cook Biotech, Inc. | 2002-04-09 | 40 | 0 |
| K001785 | SURGISIS PERIPHERAL VASCULAR PATCH | Cook Biotech, Inc. | 2000-12-27 | 197 | 1 |
| K993948 | SIS WOUND DRESSING II | Cook Biotech, Inc. | 2000-01-06 | 45 | 0 |
| K992159 | SURGISIS SLING | Cook Biotech, Inc. | 1999-09-23 | 90 | 0 |
| K980431 | SURGISIS | Cook Biotech, Inc. | 1998-05-28 | 113 | 0 |
| K973170 | SIS WOUND DRESSING | Cook Biotech, Inc. | 1998-04-30 | 248 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda