FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)
K Number: K950744
·
Decision Mar 6, 1995
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
16
Review Days
17
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Basic Information
- Device Name
- CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)
- K Number
- K950744
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stephen Chakoff, Inc.
- Date Received
- February 17, 1995
- Decision Date
- March 6, 1995
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| 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 |
| K945420 | CHAKOFF ENDOSCOPY | Dec 8, 1994 | Substantially Equivalent |