# K161101: PolypVac Microdebrider (3.3mm and 4.0mm)

- Pathway: 510(k) (Special)
- Applicant: Laurimed, LLC
- Decided: Jun 22, 2016 after 64 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: 3 generations back to K002224 (2000). 3 ancestors in all.
1 later device descends 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)
- K133133: Laurimed Polypvac Microdebrider, Laurimed, LLC (2013) Summary page 4.

## Most influential descendants
- K163247: 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (2017), 0 descendants of its own

## 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/K161101
Methodology: https://510kreport.com/methodology