# K963757: Irrigation/Suction Handle and Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Nov 26, 1996 after 69 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Suction / irrigation handle 8475.25: named in the summary without a submission number
- (no number) Suction / irrigation handle 8475.26: named in the summary without a submission number

## Indications for use
The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for irrigation fluids to be introduced into the sinus cavity. a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity. The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. - One such procedure is the VideoHydrascopic technique developed by Daniel Schuman. MD.

Source page: https://510kreport.com/device/K963757
Methodology: https://510kreport.com/methodology