# K012219: Scalpfix Clip System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Jul 31, 2001 after 15 days
- Product code: HBO (Clip, Scalp)
- Device class: 2
- Regulation: 21 CFR 882.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890443 (1989). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890443: Caspar Scalp Clip, Applier, Aesculap Instruments Corp. (1989) Summary page 1.
- K944311: Acra-Cut, Acra Cut, Inc. (1994) Summary page 1.
- K905433: Codman Disposable Scalp Clip Applier, Codman & Shurtleff, Inc. (1991). Our OCR of the scanned summary read K505433, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman & Shurtleff Disposable Scalp Clip / Applier”.

## Most influential descendants
- K132651: Itclamp 50 (2013), 2 descendants of its own
- K140805: Itclamp 50 (2014), 1 descendant of its own
- K253814: Raney Clips Kit (2026), 0 descendants of its own
- K150813: iTClamp50 (2015), 0 descendants of its own

## Indications for use
Aesculap's Scalpfix is indicated for use in temporary hemostasis of the scalp edge.

Source page: https://510kreport.com/device/K012219
Methodology: https://510kreport.com/methodology