FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE TULIP CXOMPANY BRANSON #2 ELEVATOR
K Number: K952953
·
Decision Nov 14, 1995
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
24
Review Days
141
Basic Information
- Device Name
- THE TULIP CXOMPANY BRANSON #2 ELEVATOR
- K Number
- K952953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THE TULIP MFG. CO.
- Date Received
- June 26, 1995
- Decision Date
- November 14, 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 THE TULIP MFG. CO.
| K Number | Device Name | ||
|---|---|---|---|
| K952959 | THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK | Jan 22, 1996 | Substantially Equivalent |
| K952906 | THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK | Jan 22, 1996 | Substantially Equivalent |
| K955502 | THE TULIP MONO POLAR ROTATABLE METZ SCISSORS | Jan 17, 1996 | Substantially Equivalent |
| K955501 | THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP | Jan 17, 1996 | Substantially Equivalent |
| K954734 | THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) | Nov 14, 1995 | Substantially Equivalent |
| K952958 | THE TULIP COMPANY BRANSON OVERSHEATH | Nov 14, 1995 | Substantially Equivalent |
| K952902 | THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR | Nov 14, 1995 | Substantially Equivalent |
| K952932 | THE TULIP COMPANY BRANSON #1 ELEVATOR | Nov 14, 1995 | Substantially Equivalent |
| K952951 | THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR | Nov 14, 1995 | Substantially Equivalent |
| K952901 | THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR | Nov 14, 1995 | Substantially Equivalent |