FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REFLEX INS INSUFFLATION NEEDLE
K Number: K942207
·
Decision May 27, 1994
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
8
Review Days
22
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Basic Information
- Device Name
- REFLEX INS INSUFFLATION NEEDLE
- K Number
- K942207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Richard-Allan Medical
- Date Received
- May 5, 1994
- Decision Date
- May 27, 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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Other Clearances by Richard-Allan Medical
| K Number | Device Name | ||
|---|---|---|---|
| K935105 | REFLEX ESP WITH FINGER SWITCHES | Feb 22, 1994 | Substantially Equivalent |
| K933508 | REFLEX SDD SURGICAL STAPLER | Nov 23, 1993 | Substantially Equivalent |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | Nov 19, 1993 | Substantially Equivalent |
| K924881 | REFLEX(R) ESP | Jul 23, 1993 | Substantially Equivalent |
| K924929 | REFLEX(R) ECA | Jul 21, 1993 | Substantially Equivalent |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Feb 19, 1991 | Substantially Equivalent |
| K905701 | RICHARD-ALLAN SHEET CLIP | Feb 19, 1991 | Substantially Equivalent |