FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION
K Number: K924410
·
Decision Jun 25, 1993
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
23
Review Days
298
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Basic Information
- Device Name
- LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION
- K Number
- K924410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core Dynamics, Inc.
- Date Received
- August 31, 1992
- Decision Date
- June 25, 1993
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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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 |