FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC VIDEO CAMERA
K Number: K932628
·
Decision Oct 15, 1993
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
16
Review Days
136
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Basic Information
- Device Name
- ENDOSCOPIC VIDEO CAMERA
- K Number
- K932628
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stephen Chakoff, Inc.
- Date Received
- June 1, 1993
- Decision Date
- October 15, 1993
- Product Code
- FWF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Stephen Chakoff, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940316 | HYSTERSCOPE | Nov 16, 1995 | Substantially Equivalent |
| K940317 | SINUSCOPE | May 24, 1995 | Substantially Equivalent |
| K950753 | CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO | May 15, 1995 | Substantially Equivalent |
| K951082 | CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE | Mar 22, 1995 | Substantially Equivalent |
| K950744 | CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) | Mar 6, 1995 | Substantially Equivalent |
| K950745 | CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) | Mar 6, 1995 | Substantially Equivalent |
| K950747 | CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) | Mar 6, 1995 | Substantially Equivalent |
| K950746 | CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) | Mar 6, 1995 | Substantially Equivalent |
| K950748 | CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) | Mar 6, 1995 | Substantially Equivalent |
| K945421 | CHAKOFF ENDOSCOPY | Dec 23, 1994 | Substantially Equivalent |