FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENTREE CANNULA
K Number: K911813
·
Decision Jul 19, 1991
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
8
Applicant Total
23
Review Days
87
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Basic Information
- Device Name
- ENTREE CANNULA
- K Number
- K911813
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core Dynamics, Inc.
- Date Received
- April 23, 1991
- Decision Date
- July 19, 1991
- Product Code
- FBM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBM), ordered by most recent decision date.
DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ENTREE CANNULA FASCIA ANCHORS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CANNULA AND TROCAR, 11MM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
GS-4550 TROCAR ONLY, 11MM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
GS-4100 REDUCER SLEEVE, 5MM TO 3MM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
GS-4300 CANNULA AND TROCAR, 5.5MM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Core Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992250 | CORE AUDIBLE TROCAR II | Sep 24, 1999 | Substantially Equivalent |
| K992190 | CORE POUCH | Sep 1, 1999 | Substantially Equivalent |
| K955490 | LAPAROSCOPIC KNITTER | Jan 22, 1996 | Substantially Equivalent |
| K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM | Oct 20, 1995 | Substantially Equivalent |
| K953409 | LAPAROSCOPIC TROCAR | Oct 16, 1995 | Substantially Equivalent |
| K950457 | CANNUAL AND TROCAR, SUPERPUBIC | May 5, 1995 | Substantially Equivalent |
| K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR | Jul 28, 1994 | Substantially Equivalent |
| K935826 | LAPAROSCOPIC/SUCTION/IRRIGATION PROBE | May 18, 1994 | Substantially Equivalent |
| K932118 | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET | Mar 17, 1994 | Substantially Equivalent |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Jan 11, 1994 | Substantially Equivalent |