Medilase Series 2100 Endoscope
FDA 510(k) K900894 · Medical Laser, Inc.
510(k) numberK900894
Submission
- Device name
- Medilase Series 2100 Endoscope
- Applicant
- Medical Laser, Inc.
Minneapolis, MN, US - Received
- February 27, 1990
- Decision date
- June 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCQ – Endoscope, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920979 | Codman Steerable Endoscope (Cat.# 83-1340)GCQ · Traditional | Codman & Shurtleff, Inc. | 03/23/1993SE |
| K871978 | Codman Flexible EndoscopeGCQ · Traditional | Codman & Shurtleff, Inc. | 08/25/1987SE |
| K864960 | Tv-Endoscope, Upper & Lower Gastrointestinal Appl.GCQ · Traditional | Cooper Lasersonics, Inc. | 02/10/1987SE |
| K860771 | Van-Tec Disposable Flexible EndoscopeGCQ · Traditional | Van-Tec, Inc. | 04/23/1986SE |
More from Van-Tec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913136 | Laser Endoscope Disc Decompression KitsLRO · Traditional | 11/01/1991SESK |
| K912265 | Medilase Semi-Rigid Instrod Sheath Series AE1000FED · Traditional | 10/10/1991SE |
| K912447 | Series 5000 Endoscope Console Models 5100 and 5200FET · Traditional | 09/27/1991SE |
| K912089 | Modified Series 2100 EndoscopesODF · Traditional | 08/12/1991SE |
| K901464 | Medilase Series 2200 EndoscopeGCM · Traditional | 08/07/1990SE |
| K900380 | Medilase 5010 Endoscope ConsoleFET · Traditional | 05/15/1990SE |
| K895837 | Medilase System 2010L Laser LithotriptorGEX · Traditional | 12/14/1989SE |
Questions and answers
When was Medilase Series 2100 Endoscope cleared by the FDA?
Medilase Series 2100 Endoscope (K900894) received a 510(k) decision of Substantially Equivalent on June 22, 1990, 115 days after the submission was received.
What is the product code of K900894?
The FDA product code is GCQ – Endoscope, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.1500.