FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
KAPS POSITIONING ARM
K Number: K935381
·
Decision Apr 15, 1994
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
16
Review Days
158
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
- KAPS POSITIONING ARM
- K Number
- K935381
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andronic Devices, Ltd.
- Date Received
- November 8, 1993
- Decision Date
- April 15, 1994
- Product Code
- FWZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWZ), ordered by most recent decision date.
RETRACTOR ARM CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
'LIL MAC ACCESSORY CLAMP(TM)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARBON LIGHTS HAND SURGERY TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPONGE COUNTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MIDKIFF GEOSTATIC CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| 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 |
| 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 |