510(k) · Cleared
ClearedCodman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · GXO Strip, Craniosynostosis, Preformed
Cleared on Feb 25, 2004 as substantially equivalent to K982180 (Integra Lifesciences Corp., 1999) and 1 other predicate after a 125-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 125 days
- Class
- Class II
- Product code
- GXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950956 (1995). 8 ancestors in all, the oldest K910555 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- 2 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- 1 generation backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- This deviceK033395 Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473…Codman & Shurtleff, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK152481 DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK041518 Codman Duraform Dural Graft ImplantCodman & Shurtleff, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| −2 | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| −1 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| 0 (this device) | K033395 | Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474… | Codman & Shurtleff, Inc. | 2004 | — |
| +1 | K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | 2015 | 1 |
| +1 | K041518 | Codman Duraform Dural Graft Implant | Codman & Shurtleff, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982180 | Duragen Dural Graft MatrixSummary page 2…d device vascularization. Statement of Substantial Equivalence The CODMAN Dural Graft Implant is substantially equivalent to DuraGen Dural Graft Matrix (K982180), Codman Bicol Collagen Sponge (pre- amendment), and Codman Ehtisorb TM Dura Patch (K991413) based on the subject devic… | 1999 |
| * | K991413 | Codman Ethisorb Dura PatchSummary page 2…Implant is substantially equivalent to DuraGen Dural Graft Matrix (K982180), Codman Bicol Collagen Sponge (pre- amendment), and Codman Ehtisorb TM Dura Patch (K991413) based on the subject device's similarity to the predicate devices in intended use, material, design, physical and func… | 2000 |
| * | — | Codman Bicol Collagen Sponge Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K152481 (Codman & Shurtleff, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K982180.
How does its category compare?
All GXO devicesGXO Strip, Craniosynostosis, Preformed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXO
FDA has decided no GXO device since 2007.
Median 510(k) review, days · GXO
Too few GXO 510(k)s in any year since 2007 to give a median.
Recalls per year · GXO
No recall names GXO since 2007.
Adverse event reports per year · GXO
No MAUDE report names GXO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Codman Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033395: Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033395
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026