FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPORASCOPIC CANNULA SEAL
K Number: K933025
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
17
Review Days
217
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Basic Information
- Device Name
- LAPORASCOPIC CANNULA SEAL
- K Number
- K933025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Li Medical Technologies, Inc.
- Date Received
- June 22, 1993
- Decision Date
- January 25, 1994
- 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 Li Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002413 | ULTRASORB SUTURE ANCHOR | Sep 19, 2000 | Substantially Equivalent |
| K993373 | ROTORBLADE SUTURE ANCHOR | Oct 27, 1999 | Substantially Equivalent |
| K992938 | ROTORBLADE SUTURE ANCHOR | Sep 23, 1999 | Substantially Equivalent |
| K983435 | ROTORBLADE | Apr 29, 1999 | Substantially Equivalent |
| K981755 | LM ANCHOR | Jul 13, 1998 | Substantially Equivalent |
| K981764 | LM ANCHOR | Jul 13, 1998 | Substantially Equivalent |
| K963288 | LM BONE ANCHOR | Nov 13, 1996 | Substantially Equivalent |
| K963812 | LM BONE ANCHOR (ORTHOPEDICS) | Nov 12, 1996 | Substantially Equivalent |
| K960825 | LM ANCHOR OR OTHER PROPRIETARY NAME | Apr 30, 1996 | Substantially Equivalent |
| K960439 | LM BONE ANCHOR | Apr 18, 1996 | Substantially Equivalent |