# K193346: Codman Surgical Patties & Strips

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Nov 20, 2020 after 353 days
- Product code: HBA (Neurosurgical Paddie)
- Device class: 2
- Regulation: 21 CFR 882.4700
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880402 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880402: Codman Surgical Pattie, Codman & Shurtleff, Inc. (1988) Summary page 4.

## Recalls of this device
- Sep 20, 2024 · Class II · Z-0240-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0241-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0242-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0244-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0246-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0252-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0254-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0255-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0235-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0237-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0239-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0243-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0245-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0236-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0238-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0247-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0249-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0248-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0250-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0251-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0253-2025: 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 fin
- Sep 20, 2024 · Class II · Z-0256-2025: 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 fin
- Dec 2, 2022 · Class II · Z-0909-2023: 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 fev

## Indications for use
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.

Source page: https://510kreport.com/device/K193346
Methodology: https://510kreport.com/methodology