FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE ISOLATION AND RETRIEVAL BAG
K Number: K931886
·
Decision Sep 7, 1993
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
21
Review Days
145
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Basic Information
- Device Name
- TISSUE ISOLATION AND RETRIEVAL BAG
- K Number
- K931886
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Surgical, Inc.
- Date Received
- April 15, 1993
- Decision Date
- September 7, 1993
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
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Other Clearances by Advanced Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950126 | ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE | Apr 13, 1995 | Substantially Equivalent |
| K950005 | TROCAR CANNULA STABILIZER | Jan 18, 1995 | Substantially Equivalent |
| K945369 | LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE | Nov 22, 1994 | Substantially Equivalent |
| K933497 | LAPAROSCOPIC COVERED SURGICAL RETRACTOR | May 12, 1994 | Substantially Equivalent |
| K941500 | TISSUE ISOLATION AND RETRIEVAL BAG | Apr 19, 1994 | Substantially Equivalent |
| K931850 | VERRSS PNEUMO NEEDLE | Apr 7, 1994 | Substantially Equivalent |
| K934807 | PUNCTURE CLOSURE DEVICE | Mar 1, 1994 | Substantially Equivalent |
| K932540 | LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE | Feb 17, 1994 | Substantially Equivalent |
| K940193 | SURGICAL RETRACTOR KIT | Feb 15, 1994 | Substantially Equivalent |
| K935878 | GLASSER SUTURE NEEDLE | Feb 9, 1994 | Substantially Equivalent |