FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
K Number: K033842
·
Decision Mar 4, 2004
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
1
Review Days
85
Basic Information
- Device Name
- NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
- K Number
- K033842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VERNON-CARUS LIMITED
- Date Received
- December 10, 2003
- Decision Date
- March 4, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
Disposable Trocars
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8 mm Assist Cannula; 12 mm Assist Cannula
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Boehringer Laboratories Liver Retractor
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medical Monitor (32HS710S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arthrex Synergy Vision Endoscopic Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAGIS Suction Irrigation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology