FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ARTHROBOT BI-FOLD DRAPE
K Number: K932253
·
Decision Feb 3, 1994
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
16
Review Days
269
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Basic Information
- Device Name
- ARTHROBOT BI-FOLD DRAPE
- K Number
- K932253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andronic Devices, Ltd.
- Date Received
- May 10, 1993
- Decision Date
- February 3, 1994
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Andronic Devices, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K940812 | INSIGHT ELECTRONIC ALIGNMENT INDICATOR | Nov 21, 1994 | Substantially Equivalent |
| K934926 | INSITE MODEL 20 & MODEL 15 INSUFFLATORS | May 26, 1994 | Substantially Equivalent |
| K934928 | INSITE FILTER & TUBING SET | May 26, 1994 | Substantially Equivalent |
| K935381 | KAPS POSITIONING ARM | Apr 15, 1994 | Substantially Equivalent |
| K934124 | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM | Apr 13, 1994 | Substantially Equivalent |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Mar 31, 1994 | Substantially Equivalent |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Oct 19, 1992 | Substantially Equivalent |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Oct 19, 1992 | Substantially Equivalent |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Aug 2, 1991 | Substantially Equivalent |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Aug 2, 1991 | Substantially Equivalent |