FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATS 500 TOURNIQUET
K Number: K853802
·
Decision Oct 7, 1985
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
33
Applicant Total
55
Review Days
26
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Basic Information
- Device Name
- ATS 500 TOURNIQUET
- K Number
- K853802
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Aspen Laboratories, Inc.
- Date Received
- September 11, 1985
- Decision Date
- October 7, 1985
- Product Code
- KCY
- 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 |
|---|---|---|---|
| KCY | Tourniquet, Pneumatic | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Aspen Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | Apr 21, 1998 | Substantially Equivalent |
| K963088 | SHEATH, ELECTROSURGICAL PENCIL | Sep 13, 1996 | Substantially Equivalent |
| K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT | Jul 11, 1996 | Substantially Equivalent |
| K960296 | 4000 ETM | Feb 20, 1996 | Substantially Equivalent |
| K953081 | BEAMER PLUS | Oct 30, 1995 | Substantially Equivalent |
| K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT | Aug 21, 1995 | Substantially Equivalent |
| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | Apr 3, 1995 | Substantially Equivalent |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR | Dec 21, 1994 | Substantially Equivalent |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | Apr 16, 1993 | Substantially Equivalent |
| K913213 | SINGLE USE LEE ELECTRODE | Feb 13, 1992 | Substantially Equivalent |