# K972453: XPS Straightshot Microresector

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Sep 5, 1997 after 67 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: 1 generation back to K954715 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954715: Micro-Planer Handpiece, Trebay Medical Corp. (1995) Summary page 2.

## Indications for use
This device is intended for the cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures. Indications: Any ENT, otorhinolaryngological, or head and neck surgery requiring the incision and removal of bone or tissue, including removal and shaping of bone during rhinoplasty procedures and removal of soft tissue during plastic, reconstructive, and/or athestic surgery of the head and neck.

Source page: https://510kreport.com/device/K972453
Methodology: https://510kreport.com/methodology