FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MECTRA TROCAR
K Number: K934547
·
Decision Feb 18, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
9
Review Days
149
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Basic Information
- Device Name
- MECTRA TROCAR
- K Number
- K934547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mectra Labs, Inc.
- Date Received
- September 22, 1993
- Decision Date
- February 18, 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 Mectra Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113080 | TUBALGATOR | Jun 29, 2012 | Substantially Equivalent |
| K033880 | ELECTRO-LUBE | Mar 10, 2004 | Substantially Equivalent |
| K021247 | PNEUMOPERITONEUM INSUFFLATION NEEDLE | Nov 8, 2002 | Substantially Equivalent |
| K993604 | ENDOSCOPIC ANTI FOG DEVICE | Mar 3, 2000 | Substantially Equivalent |
| K955352 | SUCTION CAUTERY PROBE | Apr 5, 1996 | Substantially Equivalent |
| K935382 | GRASPERS | Feb 15, 1994 | Substantially Equivalent |
| K925691 | INSUFFLATION TUBING | Sep 23, 1993 | Substantially Equivalent |
| K920959 | INSUFFLATOR, LAPAROSCOPIC | Jul 13, 1992 | Substantially Equivalent |