# K201752: Disposable Pre-calibrated Suction

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jan 29, 2021 after 217 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K983831 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082060: Cranial Image Guided Surgery System, Brainlab AG (2009) Summary page 4.
- K092467: Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited, Brainlab AG (2010) Summary page 4.

## Indications for use
Disposable Pre-calibrated Suction is an accessory of the Cranial Image Guided Surgery System and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial Image Guided Surgery System may be indicated. Surgical example procedures include: * Cranial resection of tumors and other lesions * Resection of skull base tumors or other lesions * AVM Resection

Source page: https://510kreport.com/device/K201752
Methodology: https://510kreport.com/methodology