# K012527: Ksea Sialoendoscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 1, 2001 after 87 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
No predicates in its family tree.
13 later devices descend from it; 6 cite it directly.
0 of 14 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 no predicate by number.

## Most influential descendants
- K070752: Ksea Miniature Endoscope, Model 11565 (2007), 6 descendants of its own
- K082569: Entellus Medical Flexible Endoscope and Eyepiece (2008), 5 descendants of its own
- K162916: 3NT endoscopy system (2017), 3 descendants of its own
- K051073: Midiview Series of Microendoscopes (2006), 2 descendants of its own
- K072749: Sialo Balloon Dilatation Catheter (2008), 1 descendant of its own

## Indications for use
The KSEA Sialoendoscopes and Accessories are for use by qualified surgeons in the diagnosis and treatment of salivary gland diseases. The Sialoendoscope is used to visualize the surgical site in salivary gland diagnostic and therapeutic procedures. The sheath is to protect the telescope. The obturator allows the surgeon to gain access to the surgical site without damaging other tissue layers. The grasping forceps are used to hold, grasp and remove stone fragments. The stone basket is used to entrap and remove stone fragments in salivary gland endoscopic therapeutic procedures.

Source page: https://510kreport.com/device/K012527
Methodology: https://510kreport.com/methodology