Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath
FDA 510(k) K072521 · Cook Urological, Inc.
510(k) numberK072521
Submission
- Device name
- Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- September 7, 2007
- Decision date
- November 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFS – Image, Illumination, Fiberoptic, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061622 | PS SeriesFFS · Traditional | Photonic Optische Gerate Gesmbh & Cokg | 03/05/2007SE |
| K063309 | Tru-CableFFS · Traditional | Truphatek International, Ltd. | 01/12/2007SE |
| K061025 | Accutech Endolite ProbeFFS · Traditional | Accutech Medical Technologies, Inc. | 05/31/2006SE |
| K023633 | Sovis Optique's Endoscopic CableFFS · Traditional | Sovis Optique | 12/31/2002SE |
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional | Cogent Light Technologies, Inc. | 07/17/2000SE |
| K994084 | Smith & Nephew Xenon Light Sources and AccessoriesFFS · Traditional | Smith & Nephew, Inc. | 01/20/2000SE |
| K991323 | Smith & Nephew Subcutaneous IlluminatorFFS · Traditional | Smith & Nephew, Inc. | 07/06/1999SE |
| K983714 | Solartec Source 270, Model # 90123FFS · Traditional | Cogent Light Technologies, Inc. | 12/23/1998SE |
| K982462 | Fiber Optic Endoillumination ProbeFFS · Traditional | Microvision, Inc. | 09/14/1998SE |
| K980636 | Fiber Optic Endoillumination ProbeFFS · Traditional | Dutch Ophthalmic USA, Inc. | 05/20/1998SE |
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| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
| K060908 | Sonohysterography Biopsy DevicePGK · Traditional | 06/29/2006SE |
Questions and answers
When was Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath cleared by the FDA?
Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath (K072521) received a 510(k) decision of Substantially Equivalent on November 20, 2007, 74 days after the submission was received.
What is the product code of K072521?
The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.