# K082637: Cranial Perforator

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Dec 22, 2008 after 103 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K791101 (1979). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982991: Anspach Access Cranial Perforator, The Anspach Effort, Inc. (1998) Summary page 1.
- K933894: Disposable Perforator, Codman & Shurtleff, Inc. (1993) Summary page 1.
- K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223, Codman & Shurtleff, Inc. (2007) Summary page 1.
- K791101: Disposable Perforators, Jacobs, Hudson, Codman & Shurtleff, Inc. (1979) Summary page 1.
- K892866: Automatic Cranial Drill (Perforator), Acra Cut, Inc. (1989) Summary page 1.
- K833266: Acra-Cut, Acra Cut, Inc. (1983) Summary page 1.

## Indications for use
The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

Source page: https://510kreport.com/device/K082637
Methodology: https://510kreport.com/methodology