Mini-Ub Endoscopes
FDA 510(k) K941230 · Candela Laser Corp.
510(k) numberK941230
Submission
- Device name
- Mini-Ub Endoscopes
- Applicant
- Candela Laser Corp.
Wayland, MA, US - Received
- March 15, 1994
- Decision date
- June 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K933106 | EndoscopeODF · Traditional | Origin Medsystems, Inc. | 10/19/1993SE |
| K912089 | Modified Series 2100 EndoscopesODF · Traditional | Medical Laser, Inc. | 08/12/1991SE |
| K910732 | Candela Mini-Ub EndoscopeODF · Traditional | Candela Laser Corp. | 04/12/1991SE |
More from Candela Laser Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K951033 | Andela Dynamic Cooling DeviceIMD · Traditional | 08/15/1996SE |
| K955662 | Candela Q-Switched Alexandrite LasersGEX · Traditional | 06/14/1996SE |
| K955011 | Candela HCS 2000 Uretheral Warmer CatheterGEH · Traditional | 04/03/1996SE |
| K954872 | Candela Cryo-Probe HolderGEH · Traditional | 02/05/1996SE |
| K954934 | Candela SPTL Long Pulse/Tunable Pulsed Dye LaseGEX · Traditional | 02/02/1996SE |
| K953412 | Candela Model PLTL-1 Laser SystemGEX · Traditional | 10/24/1995SE |
| K953294 | Candela Cryosystem CS-5GEH · Traditional | 10/18/1995SE |
| K950831 | AlexlazrGEX · Traditional | 05/26/1995SE |
| K946386 | Candela Ruby Laze Q-Switched Ruby LaserGEX · Traditional | 03/24/1995SE |
| K950661 | Candela 10MM Circular Spot Laser HandpieceGEX · Traditional | 03/10/1995SE |
Questions and answers
When was Mini-Ub Endoscopes cleared by the FDA?
Mini-Ub Endoscopes (K941230) received a 510(k) decision of Substantially Equivalent on June 17, 1994, 94 days after the submission was received.
What is the product code of K941230?
The FDA product code is ODF – Mini Endoscope, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.