# K133133: Laurimed Polypvac Microdebrider

- Pathway: 510(k) (Traditional)
- Applicant: Laurimed, LLC
- Decided: Dec 23, 2013 after 84 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002224 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041413: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 2.

## Most influential descendants
- K161101: PolypVac Microdebrider (3.3mm and 4.0mm) (2016), 1 descendant of its own
- K163247: 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (2017), 0 descendants of its own

## Recalls of this device
- Apr 7, 2014 · Class III · Z-1527-2014: The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.

## Indications for use
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

Source page: https://510kreport.com/device/K133133
Methodology: https://510kreport.com/methodology