# K093665: Endo Smartcap

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Dec 15, 2009 after 20 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790071 (1979). 2 ancestors in all.
18 later devices descend from it; 9 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790071: Endoscope and Accessories, Olympus Corp. (1979) Summary page 4.
- K971125: Endo Smartcap (100501), Endo Smart Cap Co. (1997) Summary page 4.

## Most influential descendants
- K102855: Universal Irrigation Solution Hybrid (2010), 7 descendants of its own
- K103696: Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes (2011), 3 descendants of its own
- K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1 (2013), 2 descendants of its own
- K203350: ENDOtube (2021), 1 descendant of its own
- K162152: Erbe’s CO2 Tubing/Cap Sets (2016), 1 descendant of its own

## Recalls of this device
- Oct 9, 2019 · Class II · Z-1777-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu
- Oct 9, 2019 · Class II · Z-1772-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu
- Oct 9, 2019 · Class II · Z-1776-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu
- Oct 9, 2019 · Class II · Z-1773-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu
- Oct 9, 2019 · Class II · Z-1778-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu
- Oct 9, 2019 · Class II · Z-1775-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu
- Oct 9, 2019 · Class II · Z-1774-2020: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insu

## Indications for use
The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Source page: https://510kreport.com/device/K093665
Methodology: https://510kreport.com/methodology