FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC CAMERA TC804/C4
K Number: K014158
·
Decision Mar 14, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
7
Review Days
85
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Basic Information
- Device Name
- ENDOSCOPIC CAMERA TC804/C4
- K Number
- K014158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- World of Medicine Lemke GmbH
- Date Received
- December 19, 2001
- Decision Date
- March 14, 2002
- 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 World of Medicine Lemke GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K024251 | SIGHTFIX | Mar 18, 2003 | Substantially Equivalent |
| K023468 | ENDOSCOPIC LIGHT SOURCE XL180/L3 | Jan 14, 2003 | Substantially Equivalent |
| K021717 | ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 | Aug 20, 2002 | Substantially Equivalent |
| K021456 | ER150/M2 | Aug 1, 2002 | Substantially Equivalent |
| K020889 | ENDOSCOPIC LIGHT SOURCE XL202/L3 | Jun 5, 2002 | Substantially Equivalent |
| K020336 | ENDOSCOPIC CAMERA MC404/C3 | Mar 14, 2002 | Substantially Equivalent |