# K163247: 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

- Pathway: 510(k) (Traditional)
- Applicant: Laurimed, LLC
- Decided: Mar 9, 2017 after 111 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161101: PolypVac Microdebrider (3.3mm and 4.0mm), Laurimed, LLC (2016) Summary page 4.
- K041413: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 4.

## Indications for use
The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures: ethmoidectomy, maxillary antrostomy, polypectomy, turbinectomy / turbinate reduction, sphenoidotomy, and frontal recess dissection.

Source page: https://510kreport.com/device/K163247
Methodology: https://510kreport.com/methodology