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General product and regulatory information for lab, clinic and supply staff. It is not medical advice and does not describe how any surgical device is used on a patient.
Short answer
A cottonoid is a small, flat pad of cotton or rayon used during neurosurgery to protect nervous tissue, absorb fluid or help control bleeding. In the United States FDA files cottonoids, surgical patties and neuro patties under one device name, “neurosurgical paddie” (product code HBA, 21 CFR 882.4700), a Class II device. Products in this group are sold sterile and single use.
Definition and scope
The federal regulation states the definition in one sentence: “A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.” The same section classifies the device as Class II (performance standards) (21 CFR 882.4700, Legal Information Institute copy of the eCFR, checked 2026-10-30).
FDA’s product classification database lists the device under product code HBA, medical specialty Neurology, regulation number 882.4700, device class 2, and records that it is not exempt from good manufacturing practice requirements (openFDA device classification record for HBA, checked 2026-10-30). Class II devices are generally cleared through a 510(k) premarket notification rather than premarket approval. See the CASRAI guide to FDA device classification, 510(k) and PMA pathways.
How cottonoids are described in regulatory and product records
Three public records show how the product is described.
- FDA 510(k) K193346. The posted summary for Integra LifeSciences’ Codman Surgical Patties & Strips describes single-use, sterile, radiopaque devices used during neurosurgery to protect brain and central nervous system tissue, with product code HBA. The openFDA 510(k) record lists the clearance type as Traditional, the decision as Substantially Equivalent and the decision date as 2020-11-20. The summary reports radiopacity assessed against ASTM F640-12 and ethylene oxide sterilization validated to a 10-6 sterility assurance level under ISO 11135:2014.
- NLM AccessGUDID record M731K91069. A Spetzler Neuro Patties listing describes a pattie 1/8 inch wide by 2-1/2 inches long, 0.35 mm material thickness, sterile, X-ray detectable, made of tissue-compatible rayon, for single use, packed 10 patties per pouch and 20 pouches per box. The same record states that the labeling does not contain MRI safety information (checked 2026-10-30).
- GMDN term “Cottonoid pad”. The AccessGUDID record maps the product to this Global Medical Device Nomenclature term, defined as a cushion-like mass of cotton or man-made fibres used during surgery (for example neurosurgery) to protect tissue, absorb fluids and/or stop bleeding, and single use. The record marks the term’s status as obsolete.
Names and types: cottonoid, surgical patties, neurosurgical patties, neuro patties
The same product family is sold and searched under several names. The table maps each name to where it appears in the sources above; it is a naming cross-walk, not a ranking of products.
| Name | Where it appears |
|---|---|
| Neurosurgical paddie | The FDA device name and the title of 21 CFR 882.4700 (product code HBA) |
| Surgical patties (and strips) | The trade name in 510(k) K193346, Codman Surgical Patties & Strips |
| Neuro patties / neuro pattie | The product name and description in the AccessGUDID Spetzler record |
| Cottonoid pad | The GMDN term attached to the AccessGUDID record (status: obsolete) |
Why “neuro patties sizes” has no single answer
Dimensions are set by each manufacturer and catalogue number, not by the regulation. The AccessGUDID record above lists 1/8 inch by 2-1/2 inches at 0.35 mm thickness; other records for the same product line differ in width, length and thickness. Size must therefore be read from the specific product’s labeling or its AccessGUDID record, using the catalogue number or UDI.
Where it matters for labs, clinics and supply decisions
A specification checklist drawn from the records above, useful when comparing two listings that use different names for the same device family:
| Attribute to confirm in the labeling | What the sources show |
|---|---|
| FDA product code and regulation | HBA, 21 CFR 882.4700, Class II |
| Sterile or non-sterile | Both records describe the device as sterile |
| Single use | Both records describe single use |
| X-ray detectability | Described as radiopaque (K193346) or X-ray detectable (AccessGUDID record) |
| Material | Rayon in the AccessGUDID record; the GMDN term allows cotton or man-made fibres |
| Dimensions and thickness | Stated per catalogue number; varies by product |
| MRI safety statement | Absent from the AccessGUDID record |
| Pack configuration | Stated per catalogue number (the AccessGUDID record: 10 per pouch, 20 pouches per box) |
Two related CASRAI pages explain the surrounding concepts: when sterile and non-sterile classifications matter for purchasing, and retained surgical item prevention, which covers counting and adjunct technology for items used in operating rooms. For a plain description of another absorbent surgical material, see what is gauze.
Common misunderstandings
“Cleared” does not mean “approved”
A 510(k) decision of Substantially Equivalent means FDA found the device substantially equivalent to a legally marketed predicate. It is not a premarket approval. The distinction is covered in FDA clearance vs. approval.
“Cottonoid” is not a regulatory name
Searching FDA’s classification database for “cottonoid” will not find the device class; the regulatory name is “neurosurgical paddie”. Searching by product code HBA lists the products cleared under that code.
“Patty” and “pattie” are the same product family
Spellings differ between manufacturers and records (“patties”, “pattie”, “paddie”). The spelling does not indicate a different device class.
FAQ
What is a cottonoid?
A small pad of cotton or rayon used in neurosurgery to protect nervous tissue, absorb fluid or help control bleeding, regulated by FDA as a neurosurgical paddie.
Are surgical patties and neurosurgical patties the same thing?
“Surgical patties” is a manufacturer trade name cleared under the same product code (HBA) as the regulation’s “neurosurgical paddie”, so they belong to the same device group.
What FDA class is a neurosurgical paddie?
Class II, under 21 CFR 882.4700.
What sizes do neuro patties come in?
Sizes vary by manufacturer and catalogue number; the regulation sets none. Read the dimensions from the labeling or the product’s AccessGUDID record.
Sources
All sources checked 2026-10-30.
- 21 CFR 882.4700, Neurosurgical paddie: https://www.law.cornell.edu/cfr/text/21/882.4700
- FDA product classification database, product code HBA: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=HBA
- openFDA device classification and 510(k) records (HBA, K193346): https://open.fda.gov/apis/device/
- NLM AccessGUDID, device record M731K91069: https://accessgudid.nlm.nih.gov/devices/M731K91069
- FDA 510(k) K193346, Codman Surgical Patties & Strips, Integra LifeSciences: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193346
