# K013680: Carbodissecting Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Endo Surgical Devices, Inc.
- Decided: Mar 4, 2002 after 117 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) Sobel-Kaplitt-Sawyer Gas Spatula: named in the summary without a submission number
- (no number) Cook Urological CO2 Pneumo-Dissector: named in the summary without a submission number
- (no number) Guidant Corporation — Origin Medsystems VasoView Balloon Dissection System: named in the summary without a submission number

## Most influential descendants
- K020925: Carbodissecting Endoscope (2003), 0 descendants of its own

## Indications for use
To gently dissect planes of soft tissue using controlled bursts of CO2 gas. The device may be used in both open and endoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.

Source page: https://510kreport.com/device/K013680
Methodology: https://510kreport.com/methodology