# K981751: Sinuscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Henke Sass Wolf of America, Inc.
- Decided: Aug 13, 1998 after 87 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 K874215 (1988). 2 ancestors in all.
3 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)
- K932988: Accessories for Endoscopes for Sinus Surgery, Smith & Nephew Richards, Inc. (1993) Summary page 1.
- K874215: Endoscopes for Sinus Surgery, Richards Medical Co., Inc. (1988) Summary page 1.

## Most influential descendants
- K032822: Asap Sinuscope 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 (2004), 2 descendants of its own
- K082667: Visionsense Stereoscopic Vision System (VS System) (2008), 1 descendant of its own
- K162410: TIPCAM 1S 3D System (2017), 0 descendants of its own

## Indications for use
The HENKE-SASS WOLF of America Inc., Sinuscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic sinus surgical procedures. The HENKE SASS WOLF of America Inc. Sinuscope Accessories will include Sheaths - to establish portals for visualization and surgical access and the Suction/Irrigation Handle - to remove debris and body fluids from the surgical site and to provide irrigation of the site with a sterile solution such as saline water. The Sinuscope and accessories are indicated for use in, but not t limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.

Source page: https://510kreport.com/device/K981751
Methodology: https://510kreport.com/methodology