# K971837: Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Aug 6, 1997 after 79 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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) Gynescope Trocar and Sleeves: named in the summary without a submission number
- (no number) Marlow Verres Needle: named in the summary without a submission number

## Indications for use
Verres Needle and Cannula is intended for use in laparoscopic surgery that utilizes minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.

Source page: https://510kreport.com/device/K971837
Methodology: https://510kreport.com/methodology