# K180063: OCM-G1 Attachment

- Pathway: 510(k) (Special)
- Applicant: The Anspach Effort, Inc.
- Decided: Mar 27, 2018 after 77 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002224 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131053: Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System, The Anspach Effort, Inc. (2013) Summary page 4.

## Indications for use
When used with the ANSPACH® Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

Source page: https://510kreport.com/device/K180063
Methodology: https://510kreport.com/methodology