Medilase Series 2200 Endoscope
FDA 510(k) K901464 · Medical Laser, Inc.
510(k) numberK901464
Submission
- Device name
- Medilase Series 2200 Endoscope
- Applicant
- Medical Laser, Inc.
Minneapolis, MN, US - Received
- March 28, 1990
- Decision date
- August 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCM – Endoscope, Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | Richard Wolf Medical Instruments Corporation | 05/14/2021SE |
| K083840 | Msi Medserv International-Rigid EndoscopeGCM · Traditional | Msi Medserv International Deutschland GmbH | 09/28/2009SE |
| K001217 | Inside ViewGCM · Traditional | Monadnock Optics, Inc. | 07/11/2000SE |
| K993103 | ENDOSCOPES,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes…GCM · Traditional | Richard Wolf Medical Instruments Corp. | 12/10/1999SE |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | Omnisonics Medical Technologies | 12/06/1999SE |
| K962393 | Ksea Set for Endoscopic Assisted IntubationGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/17/1996SE |
| K950712 | Portable Endoscopy SystemGCM · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 05/14/1996SE |
| K955120 | Hand-Held Retractor, Dissector & DissectorGCM · Traditional | Ethicon Endo-Surgery, Inc. | 01/26/1996SE |
| K935235 | Endoscopy System for Facial Plastic SurgeryGCM · Traditional | Smith & Nephew Richards, Inc. | 03/23/1995SE |
| K945889 | Karl Storz Plastic Surgery AccessoriesGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1995SE |
More from KARL STORZ Endoscopy-America, 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 |
| K900894 | Medilase Series 2100 EndoscopeGCQ · Traditional | 06/22/1990SE |
| 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 2200 Endoscope cleared by the FDA?
Medilase Series 2200 Endoscope (K901464) received a 510(k) decision of Substantially Equivalent on August 7, 1990, 132 days after the submission was received.
What is the product code of K901464?
The FDA product code is GCM – Endoscope, Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.