FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TROCAR
K Number: K924058
·
Decision Mar 30, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
10
Review Days
230
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Basic Information
- Device Name
- TROCAR
- K Number
- K924058
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endo Technic Corp.
- Date Received
- August 12, 1992
- Decision Date
- March 30, 1993
- 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 Endo Technic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K990908 | MILLENNIUM | May 27, 1999 | Substantially Equivalent |
| K971459 | DERMALASE | Jul 18, 1997 | Substantially Equivalent |
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | Aug 24, 1994 | Substantially Equivalent |
| K930756 | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE | Mar 9, 1994 | Substantially Equivalent |
| K925114 | LAPAROSCOPIC INSTRUMENTS | Feb 28, 1994 | Substantially Equivalent |
| K914825 | 1-125 ENDOSEED | Mar 19, 1992 | Substantially Equivalent |
| K910200 | LASER-35 | May 9, 1991 | Substantially Equivalent |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Feb 27, 1987 | Substantially Equivalent |
| K862129 | SET CANAL SEALER PASTE | Jul 22, 1986 | Substantially Equivalent |