FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
K Number: K921963
·
Decision Sep 11, 1992
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
4
Review Days
137
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
- DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
- K Number
- K921963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sun Medical, Inc.
- Date Received
- April 27, 1992
- Decision Date
- September 11, 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