Chakoff Endoscopy
FDA 510(k) K945420 · Stephen Chakoff, Inc.
510(k) numberK945420
Submission
- Device name
- Chakoff Endoscopy
- Applicant
- Stephen Chakoff, Inc.
Miami, FL, US - Received
- November 4, 1994
- Decision date
- December 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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More from Circon Video
| 510(k) | Device | Decision |
|---|---|---|
| K940316 | HysterscopeHIH · Traditional | 11/16/1995SE |
| K940317 | SinuscopeEOB · Traditional | 05/24/1995SE |
| K950753 | Chakoff Endoscopy (Camera Television Endoscopic Without AudioGCJ · Traditional | 05/15/1995SE |
| K951082 | Chakoff Endoscopy, Rigid EndoscopeGCJ · Traditional | 03/22/1995SE |
| K950748 | Chakoff Endoscopy (Fiber Optic Light Source Routine)GCJ · Traditional | 03/06/1995SE |
| K950747 | Chakoff Endoscopy (Light Source Endoscopic Xenon Arc.)GCJ · Traditional | 03/06/1995SE |
| K950746 | Chakoff Endoscopy (Set Laparoscopy)GCJ · Traditional | 03/06/1995SE |
| K950745 | Chakoff Endoscopy (Endoscope And/Or Accessories)GCJ · Traditional | 03/06/1995SE |
| K950744 | Chakoff Endoscopy (Ridgid Endoscope)GCJ · Traditional | 03/06/1995SE |
| K945421 | Chakoff EndoscopyFDG · Traditional | 12/23/1994SE |
Questions and answers
When was Chakoff Endoscopy cleared by the FDA?
Chakoff Endoscopy (K945420) received a 510(k) decision of Substantially Equivalent on December 8, 1994, 34 days after the submission was received.
What is the product code of K945420?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.