FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
INSITE MODEL 20 & MODEL 15 INSUFFLATORS
K Number: K934926
·
Decision May 26, 1994
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
174
Applicant Total
16
Review Days
224
Basic Information
- Device Name
- INSITE MODEL 20 & MODEL 15 INSUFFLATORS
- K Number
- K934926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ANDRONIC DEVICES, LTD.
- Date Received
- October 14, 1993
- Decision Date
- May 26, 1994
- 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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|---|---|---|---|
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| K934124 | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM | Apr 13, 1994 | Substantially Equivalent |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Mar 31, 1994 | Substantially Equivalent |
| K932253 | ARTHROBOT BI-FOLD DRAPE | Feb 3, 1994 | Substantially Equivalent |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Oct 19, 1992 | Substantially Equivalent |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Oct 19, 1992 | Substantially Equivalent |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Aug 2, 1991 | Substantially Equivalent |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Aug 2, 1991 | Substantially Equivalent |