Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
FDA 510(k) clearance K150927 · decided 2015-05-27
Clearance details
- K-number
- K150927
- Device name
- Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 2015-04-06
- Decision date
- 2015-05-27
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- OCY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coloplast A/S
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EasyPass Guidewire (K153264) | Medi-Globe Corporation | 2016-05-19 |
| Radifocus Glidewire Endoscopic Wire (K151471) | Terumo Medical Corporation | 2015-09-17 |
| NovaGold High Performance Guidewire (K150225) | Neometrics, Inc. | 2015-03-16 |
| Acrobat Calibrated Tip Wire Guide (K142950) | Wilson-Cook Medical, Inc. | 2014-11-05 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |
| Predicate III Guidewire (K142397) | Lake Region Medical | 2014-09-19 |
| MANDREL GUIDEWIRE (K140482) | Lake Region Medical | 2014-04-08 |
| NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (K133076) | Neometrics, Inc. | 2014-02-20 |
| ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC (K131072) | Coloplast A/S | 2013-07-09 |
| OSTAVI HYDROPHILIC GUIDEWIRE (K124052) | Lake Region Medical | 2013-02-26 |
| XENX STONE MANAGEMENT DEVICE (K123438) | Xenolith Medical | 2013-01-10 |
| NEO ERCP GUIDEWIRE (K123439) | Neometrics, Inc. | 2013-01-03 |
Recalls involving this device
No recalls on record reference this clearance.