Medilase Series 2100 Endoscope
510(k) K900894
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900894 | Date22 Jun 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
This device is a flexible endoscope, as defined in the device type and openfda fields. It is classified as a Class II medical device under regulation number 876.1500.
The device received FDA 510(k) clearance (K900894) on June 22, 1990, and is substantially equivalent to a predicate device. It is intended for use in gastroenterology and urology specialties, as indicated by the advisory committee and medical specialty description. The device is manufactured by Medical Laser, Inc. and registered under FEI numbers 3013445147, 3009756153, and 3003574398.
Other devices from Medical Laser, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Medilase Series 2100 Endoscope used for?
The Medilase Series 2100 Endoscope is intended for use in gastroenterology and urology specialties, as indicated by its FDA 510(k) clearance and medical specialty description, allowing visualization and diagnostic procedures in the gastrointestinal and urinary tracts.
How was the Medilase Series 2100 Endoscope cleared for market?
The device received FDA 510(k) clearance (K900894) on June 22, 1990, through a traditional submission pathway, demonstrating substantial equivalence to a legally marketed predicate device under regulation number 876.1500.
What regulatory classification does the Medilase Series 2100 Endoscope have?
The Medilase Series 2100 Endoscope is classified as a Class II medical device under FDA regulation number 876.1500, based on its openfda device_class field and 510(k) clearance status.