FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSUFFLATOR, MODEL G100 & 200
K Number: K772297
·
Decision Jan 5, 1978
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
18
Review Days
23
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, MODEL G100 & 200
- K Number
- K772297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kli
- Date Received
- December 13, 1977
- Decision Date
- January 5, 1978
- 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 Kli
| K Number | Device Name | ||
|---|---|---|---|
| K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE | Jun 17, 1980 | Substantially Equivalent |
| K800913 | GYNECOLOGICAL CYSTO/URETHROSCOPE | May 14, 1980 | Substantially Equivalent |
| K781913 | INSUFFALATOR LAPARAOSCOPIC | Dec 4, 1978 | Substantially Equivalent |
| K781109 | FORCEPS, ELECTROSURGICAL | Sep 14, 1978 | Substantially Equivalent |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Jul 17, 1978 | Substantially Equivalent |
| K780955 | SCISSORS, HOOK, ELECTROSURGICAL | Jun 22, 1978 | Substantially Equivalent |
| K780954 | SCISSORS, HOOK, ELECTROSURGICAL | Jun 22, 1978 | Substantially Equivalent |
| K772242 | LAPAROSCOPY CONSOLE MODEL VIII | Dec 20, 1977 | Substantially Equivalent |
| K772220 | PROBE, COAGULATION ACCESSORY | Dec 13, 1977 | Substantially Equivalent |
| K772185 | LAPAROSCOPE W/REMOVABLE OPTICS | Nov 30, 1977 | Substantially Equivalent |