# K093785: Modular Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Sialo Technology, Ltd.
- Decided: Aug 18, 2010 after 252 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926166 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012527: Ksea Sialoendoscopes and Accessories, KARL STORZ Endoscopy-America, Inc. (2001) Summary page 1.
- K051073: Midiview Series of Microendoscopes, Millennium Devices, Inc. (2006) Summary page 1.
- K050403: Spyglass Direct Visulation Probe, Boston Scientific Corp (2005) Summary page 1.
- K991011: Orascope, Fiberdent Corp. (1999). Our reading of the summary gave K991101, FDA’s number for Coag-a-Mate Max (Organon Teknika Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “OraScope”. Summary page 3.

## Indications for use
The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT Surgery, including but not limited to, salivary gland diseases.

Source page: https://510kreport.com/device/K093785
Methodology: https://510kreport.com/methodology