FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K Number: K021010
·
Decision Jun 6, 2002
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
53
Applicant Total
22
Review Days
69
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Basic Information
- Device Name
- MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
- K Number
- K021010
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endocare, Inc.
- Date Received
- March 29, 2002
- Decision Date
- June 6, 2002
- Product Code
- OCL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Endocare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K101333 | CRYOCARE CS SURGICAL SYSTEM | Jun 14, 2010 | Substantially Equivalent |
| K062175 | CRYOCARE CN2 SYSTEM | Aug 28, 2006 | Substantially Equivalent |
| K060279 | CRYOCARE CS SURGICAL SYSTEM | Feb 28, 2006 | Substantially Equivalent |
| K050347 | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM | Feb 25, 2005 | Substantially Equivalent |
| K032333 | CRYOCARE CS SURGICAL SYSTEM | Aug 12, 2003 | Substantially Equivalent |
| K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 | Dec 5, 2002 | Substantially Equivalent |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | Feb 5, 2002 | Substantially Equivalent |
| K011074 | CRYOCARE SURGICAL SYSTEM | Jan 25, 2002 | Substantially Equivalent |
| K003811 | CRYOCARE SURGICAL SYSTEM | Oct 11, 2001 | Substantially Equivalent |
| K011040 | CRYOCARE CARDIAC SURGICAL SYSTEM | Jun 15, 2001 | Substantially Equivalent |