# K990852: Coopersurgical Infrared Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jun 11, 1999 after 88 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Redfield Corporation’s Redfield Infrared Coagulator: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K970852: Magnetom Project 024 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997). Our OCR of the scanned summary read K970852, FDA’s number for Magnetom Project 024 System (Numaris 3.5 Software) (Siemens Medical Solutions USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CooperSurgical’s InfraRed Coagulator”. Kept off the family tree. Summary page 2.

## Indications for use
The CooperSurgical InfraRed Coagulator is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed through coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.

Source page: https://510kreport.com/device/K990852
Methodology: https://510kreport.com/methodology