PS Series
FDA 510(k) K061622 · Photonic Optische Gerate Gesmbh & Cokg
510(k) numberK061622
Submission
- Device name
- PS Series
- Applicant
- Photonic Optische Gerate Gesmbh & Cokg
Vienna, AT - Received
- June 12, 2006
- Decision date
- March 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FFS – Image, Illumination, Fiberoptic, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | Cook Urological, Inc. | 11/20/2007SE |
| 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 |
Questions and answers
When was PS Series cleared by the FDA?
PS Series (K061622) received a 510(k) decision of Substantially Equivalent on March 5, 2007, 266 days after the submission was received.
What is the product code of K061622?
The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.