# K121822: Delicot

- Pathway: 510(k) (Special)
- Applicant: American Surgical Company, LLC
- Decided: Sep 10, 2012 after 81 days
- Product code: HBA (Neurosurgical Paddie)
- Device class: 2
- Regulation: 21 CFR 882.4700
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862494 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902921: Rayon Neurological Sponge, American Silk Sutures, Inc. (1990) Summary page 1.
- K862494: Polyester Sponge Pattie, American Silk Sutures, Inc. (1986) Summary page 2.

## Recalls of this device
- Mar 31, 2016 · Class II · Z-1785-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1784-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1787-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1721-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1775-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1780-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1779-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1791-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1792-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1781-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1722-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1786-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1789-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1783-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1793-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1790-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1776-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1782-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1777-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1778-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1788-2016: Product packaging defective compromising sterility

## Indications for use
The device is a neurosurgical pad~ used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Source page: https://510kreport.com/device/K121822
Methodology: https://510kreport.com/methodology