# K971310: Aesculap Jet Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 18, 1997 after 101 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Codman's Malis Irrigation System: named in the summary without a submission number

## Most influential descendants
- K012986: Bipolar Irrigation Forceps (2001), 0 descendants of its own

## Indications for use
Aesculap’s Jet Irrigation System is designed for use with Aesculap’s Bipolar Coagulator. The Jet Irrigation System delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap’s Bipolar Irrigation Forceps. The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous “jet” irrigation provides a clearer visual field.

Source page: https://510kreport.com/device/K971310
Methodology: https://510kreport.com/methodology