FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM
K Number: K020082
·
Decision Feb 5, 2002
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
22
Review Days
26
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Basic Information
- Device Name
- ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM
- K Number
- K020082
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endocare, Inc.
- Date Received
- January 10, 2002
- Decision Date
- February 5, 2002
- Product Code
- LKY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
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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 |
| K021010 | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE | Jun 6, 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 |