Modified Series 2100 Endoscopes
FDA 510(k) K912089 · Medical Laser, Inc.
510(k) numberK912089
Submission
- Device name
- Modified Series 2100 Endoscopes
- Applicant
- Medical Laser, Inc.
Minneapolis, MN, US - Received
- May 13, 1991
- Decision date
- August 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ODF – Mini Endoscope, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code ODF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092739 | Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light…ODF · Traditional | C-Link Micro Imaging, Inc. | 01/12/2010SE |
| K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…ODF · Traditional | Lumenis, Inc. | 09/30/2009SE |
| K090170 | Spyscope Access and Delivery CatheterODF · Traditional | Boston Scientific Corp | 02/04/2009SE |
| K052194 | Spyglass Direct Visualization Probe and OcularODF · Traditional | Boston Scientific Corp | 08/24/2005SE |
| K050403 | Spyglass Direct Visulation ProbeODF · Traditional | Boston Scientific Corp | 03/04/2005SE |
| K963354 | 5 Star Medical EndoscopeODF · Traditional | Five Star Medical, Inc. | 09/08/1997SE |
| K943593 | Saratoga Modular Miniature Endoscope SystemODF · Traditional | Ovamed Corp. | 03/22/1995SE |
| K941230 | Mini-Ub EndoscopesODF · Traditional | Candela Laser Corp. | 06/17/1994SE |
| K933106 | EndoscopeODF · Traditional | Origin Medsystems, Inc. | 10/19/1993SE |
| K910732 | Candela Mini-Ub EndoscopeODF · Traditional | Candela Laser Corp. | 04/12/1991SE |
More from Candela Laser Corp.
| 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 |
| K901464 | Medilase Series 2200 EndoscopeGCM · Traditional | 08/07/1990SE |
| 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 Modified Series 2100 Endoscopes cleared by the FDA?
Modified Series 2100 Endoscopes (K912089) received a 510(k) decision of Substantially Equivalent on August 12, 1991, 91 days after the submission was received.
What is the product code of K912089?
The FDA product code is ODF – Mini Endoscope, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.