COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
FDA 510(k) clearance K072521 · decided 2007-11-20
Clearance details
- K-number
- K072521
- Device name
- COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-07
- Decision date
- 2007-11-20
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- FFS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook Urological
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 |
|---|---|---|
| PS SERIES (K061622) | Photonic Optische Gerate Gesmbh & Cokg | 2007-03-05 |
| TRU-CABLE (K063309) | Truphatek International, Ltd. | 2007-01-12 |
| ACCUTECH ENDOLITE PROBE (K061025) | Accutech Medical Technologies, Inc. | 2006-05-31 |
| SOVIS OPTIQUE'S ENDOSCOPIC CABLE (K023633) | Sovis Optique | 2002-12-31 |
| MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (K001698) | Cogent Light Technologies, Inc. | 2000-07-17 |
| SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084) | Smith & Nephew, Inc. | 2000-01-20 |
| SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (K991323) | Smith & Nephew, Inc. | 1999-07-06 |
| SOLARTEC SOURCE 270, MODEL # 90123 (K983714) | Cogent Light Technologies, Inc. | 1998-12-23 |
| FIBER OPTIC ENDOILLUMINATION PROBE (K982462) | Microvision, Inc. | 1998-09-14 |
| FIBER OPTIC ENDOILLUMINATION PROBE (K980636) | Dutch Ophthalmic USA, Inc. | 1998-05-20 |
| VISTA ILLUMINATION SYSTEM (K970217) | Vista Medical Technologies, Inc. | 1997-04-02 |
| KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS (K962595) | KARL STORZ Endoscopy-America, Inc. | 1996-09-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber recall (Z-2540-2017) | Cook Inc. | 2017-06-05 |