FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Instru-Safe Instrument Protection System
K Number: K142630
·
Decision Dec 23, 2014
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
9
Review Days
97
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Basic Information
- Device Name
- Instru-Safe Instrument Protection System
- K Number
- K142630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical, Inc.
- Date Received
- September 17, 2014
- Decision Date
- December 23, 2014
- Product Code
- KCT
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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Other Clearances by Summit Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K180528 | InstruSafe(R) Sterilization Container | Nov 16, 2018 | Substantially Equivalent |
| K162046 | MINNE TIES MMF Suture System | Apr 11, 2017 | Substantially Equivalent |
| K151166 | Instru-Safe Instrument Protection System | Aug 18, 2015 | Substantially Equivalent |
| K150540 | Instru-Safe Instrument Protection System | Jun 22, 2015 | Substantially Equivalent |
| K142768 | Instru-Safe Instrument Protection System | May 29, 2015 | Substantially Equivalent |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Dec 15, 2014 | Substantially Equivalent |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Jun 27, 2014 | Substantially Equivalent |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Mar 13, 2014 | Substantially Equivalent |