# K063078: Microendoscope

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Oct 24, 2006 after 14 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 K002214 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002214: Sinuscope and Baccessories, Pollux Endoscopy, Inc. (2000) Summary page 1.
- K011189: Viaduct Microendoscope and Accessories, Acueity, Inc. (2001). Our reading of the summary gave K001189, FDA’s number for Modification to Convertors Surgical Gowns (Allegiance Healthcare Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acueity ViaDuct MicroEndoscope and Accessories”.
- K010179: Ebi Vuecath Spinal Endoscopic System, Ebi, L.P. (2001) Summary page 1.

## Most influential descendants
- K100533: Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models FG0027, FG0031, FG0029, FG 0028, (2011), 1 descendant of its own
- K183264: Flex-THOR scope (2019), 0 descendants of its own

## Indications for use
The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.

Source page: https://510kreport.com/device/K063078
Methodology: https://510kreport.com/methodology