FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSUFFLATOR, LAPAROSCOPIC
K Number: K920959
·
Decision Jul 13, 1992
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
9
Review Days
139
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSUFFLATOR, LAPAROSCOPIC
- K Number
- K920959
- 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
- February 25, 1992
- Decision Date
- July 13, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIF), ordered by most recent decision date.
Insufflator (OPTO-IFL1000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOFLATOR +
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AirSurgN Insufflator (10030/AirSurgN)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
High Flow Insufflation Unit (UHI-4)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TauTona Pneumoperitoneum Assist Device (TPAD)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VereSee Optical Veres Needle System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K934547 | MECTRA TROCAR | Feb 18, 1994 | Substantially Equivalent |
| K935382 | GRASPERS | Feb 15, 1994 | Substantially Equivalent |
| K925691 | INSUFFLATION TUBING | Sep 23, 1993 | Substantially Equivalent |