Cell Recovery System
FDA 510(k) K960004 · Medical Device Technologies, Inc.
510(k) numberK960004
Submission
- Device name
- Cell Recovery System
- Applicant
- Medical Device Technologies, Inc.
San Diego, CA, US - Received
- January 2, 1996
- Decision date
- March 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDX – Endoscopic Cytology Brush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To collect cells for cytological evaluation.
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| K151889 | Infinity ERCP Sampling DeviceFDX · Special | United States Endoscopy Group, Inc. | 07/30/2015SE |
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| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
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Questions and answers
When was Cell Recovery System cleared by the FDA?
Cell Recovery System (K960004) received a 510(k) decision of Substantially Equivalent on March 20, 1996, 78 days after the submission was received.
What is the product code of K960004?
The FDA product code is FDX – Endoscopic Cytology Brush, a Class II (moderate risk) device regulated under 21 CFR 876.1500.