FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PNEUMOPERITONEUM INSUFFLATION NEEDLE
K Number: K021247
·
Decision Nov 8, 2002
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
9
Review Days
203
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Basic Information
- Device Name
- PNEUMOPERITONEUM INSUFFLATION NEEDLE
- K Number
- K021247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mectra Labs, Inc.
- Date Received
- April 19, 2002
- Decision Date
- November 8, 2002
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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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 |
| K993604 | ENDOSCOPIC ANTI FOG DEVICE | Mar 3, 2000 | Substantially Equivalent |
| K955352 | SUCTION CAUTERY PROBE | Apr 5, 1996 | Substantially Equivalent |
| K934547 | MECTRA TROCAR | Feb 18, 1994 | 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 |