# K982594: Endo-Scrub/Endo-Scrub 2

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Aug 27, 1998 after 34 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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: 1 generation back to K902683 (1990). 1 ancestor in all.
23 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902683: Scopescrubber (TM), Healthtek Microsurgical, Inc. (1990) Summary page 1.

## Most influential descendants
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own
- K170103: Laparoscope Lens Shield Device (LENS) (2017), 6 descendants of its own
- K192891: Laparoscope Lens Shield Device (LENS) (2019), 4 descendants of its own

## Recalls of this device
- Jan 29, 2004 · Not classified · Z-0954-04: The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.

## Indications for use
The Endo-Scrub 2 is intended to clear the end of a rigid rod endoscope, in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments and lasers.

Source page: https://510kreport.com/device/K982594
Methodology: https://510kreport.com/methodology