FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNITED SURGICAL CORP. CRYOPTIC PLUS
K Number: K870195
·
Decision Feb 20, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
7
Review Days
31
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Basic Information
- Device Name
- UNITED SURGICAL CORP. CRYOPTIC PLUS
- K Number
- K870195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- United Surgical Corp.
- Date Received
- January 20, 1987
- Decision Date
- February 20, 1987
- Product Code
- HPS
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HPS | Unit, Cryophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by United Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K902150 | PIEZO HANDPIECE | Jul 5, 1990 | Substantially Equivalent |
| K870671 | PHACOTRON DAY PAK | Apr 6, 1987 | Substantially Equivalent |
| K870806 | NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 | Mar 26, 1987 | Substantially Equivalent |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | Feb 20, 1987 | Substantially Equivalent |
| K860014 | SYSTEMS PLUS | Mar 5, 1986 | Substantially Equivalent |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | Aug 11, 1983 | Substantially Equivalent |