Olympus Capsule Endoscope System
by Olympus Medical Systems Corporation
510(k) K063259
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063259 | Date14 Sep 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NEZ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1300
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Olympus Capsule Endoscope System EC-10 is a wireless imaging system designed for gastrointestinal capsule endoscopy. It captures high-resolution images of the small intestine as the ingestible capsule passes through the digestive tract, enabling non-invasive visualization of the mucosal lining and detection of abnormalities such as bleeding, polyps, or tumors. Classified as a Class II medical device, it operates using a miniature camera housed within a swallowable capsule that transmits data wirelessly to an external receiver.
The system is intended for single-use and requires no sterilization. It consists of a capsule, a receiver unit, and a control unit for image processing and storage. The capsule is ingested by the patient, while the receiver and control unit are worn externally during the procedure. The device is regulated under FDA 510(k) clearance (K063259) and is intended for use in gastroenterology and urology settings. Storage and handling follow standard medical device protocols to ensure functionality and patient safety.
Other devices from Olympus Medical Systems Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Olympus EC-10 Capsule Endoscope System used for?
The Olympus EC-10 Capsule Endoscope System is designed for gastrointestinal capsule endoscopy, allowing clinicians to visualize the small intestine’s mucosal lining non-invasively. It helps detect abnormalities such as bleeding, polyps, or tumors by capturing high-resolution images as the ingestible capsule passes through the digestive tract. This is particularly useful in gastroenterology and urology for diagnosing conditions that may not be visible through traditional endoscopy.
How is the Olympus EC-10 Capsule Endoscope System supplied and intended for use?
The system consists of three main components: a single-use capsule, an external receiver unit, and a control unit for image processing and storage. The capsule is ingested by the patient, while the receiver and control unit are worn externally during the procedure. It is intended for single-use only, eliminating the need for sterilization, and is regulated under FDA 510(k) clearance (K063259).
Is the Olympus EC-10 Capsule Endoscope System reusable or single-use?
The Olympus EC-10 Capsule Endoscope System is explicitly designed for single-use. This design ensures patient safety by eliminating the risk of cross-contamination and simplifies handling and disposal protocols. The capsule, receiver, and control unit are not intended for reuse, adhering to standard medical device guidelines for disposable imaging systems.
What storage and handling guidelines should be followed for the Olympus EC-10 Capsule Endoscope System?
The system must be stored and handled according to standard medical device protocols to maintain functionality and ensure patient safety. The capsule should be stored in its original packaging until use, protected from moisture, extreme temperatures, and physical damage. The receiver and control unit should be kept in a clean, dry environment, away from direct sunlight or sources of electromagnetic interference. Always follow manufacturer instructions for proper storage and disposal.
What regulatory pathway does the Olympus EC-10 Capsule Endoscope System follow?
The Olympus EC-10 Capsule Endoscope System is regulated under the FDA’s 510(k) clearance pathway, specifically classified as a Class II medical device. It was granted clearance under the designation K063259, with a decision of Substantially Equivalent (SESE) by the Gastroenterology and Urology (GU) advisory committee. This pathway ensures the device meets established safety and performance standards for wireless gastrointestinal imaging systems.