510(k) · Cleared
Recalled · Class II · 2024Codman Surgical Patties & Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · HBA Neurosurgical Paddie
Cleared on Nov 20, 2020 as substantially equivalent to K880402 (Codman & Shurtleff, Inc., 1988) after a 353-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 23 times.
- Decided
- Nov 20, 2020
- Review
- 353 days
- Class
- Class II
- Product code
- HBA
- Recalls
- 23
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880402 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880402 Codman Surgical PattieCodman & Shurtleff, Inc. · 1988 · Recalled
- This deviceK193346 Codman Surgical Patties & StripsIntegra LifeSciences Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880402 | Codman Surgical Pattie | Codman & Shurtleff, Inc. | 1988 | 3 |
| 0 (this device) | K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | 2020 | — |
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 HBA? 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? (1)
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 |
|---|---|---|---|
| * | K880402 | Codman Surgical PattieSummary page 4…BA Review Panel Neurology III. Predicate The predicate device for this submission is the Codman® Surgical Pattie Device (K880402), which was cleared on March 2, 1988. IV. Device The Codman Surgical Patties and Strips are single use, sterile devices i… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2024 | Class II | Z-0240-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0241-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0242-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0244-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0246-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0252-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0254-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0255-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0235-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0237-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0239-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0243-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0245-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0236-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0238-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0247-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0249-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0248-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0250-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0251-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0253-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Sep 20, 2024 | Class II | Z-0256-2025 | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Dec 2, 2022 | Class II | Z-0909-2023 | Process control | Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever. |
The 5 latest of 23 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K880402.
How does its category compare?
All HBA devicesHBA Neurosurgical Paddie: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HBA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HBA
Too few HBA 510(k)s in any year since 2007 to give a median.
Recalls per year · HBA
23in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBA
5in 2025
MAUDE reports naming product code HBA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 12 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 3 | 25 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 1 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 40 |
| 2017 | 0 | — | 0 | 35 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 0 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 44 |
| 2022 | 0 | — | 1 | 28 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 23 | 27 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193346: Codman Surgical Patties & Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193346
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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