FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
K Number: K011195
·
Decision Nov 6, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
23
Review Days
201
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Basic Information
- Device Name
- PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
- K Number
- K011195
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgin Surgical Instrumentation, Inc.
- Date Received
- April 19, 2001
- Decision Date
- November 6, 2001
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Surgin Surgical Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082110 | DUAL SYRINGE HOLDER | Jun 17, 2009 | Substantially Equivalent |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | Mar 26, 2004 | Substantially Equivalent |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Jan 30, 2004 | Substantially Equivalent |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | Mar 15, 2000 | Substantially Equivalent |
| K980849 | SURGIN KIT | Jul 9, 1998 | Substantially Equivalent |
| K954238 | SURGIN GENISIS HANDPIECE | Dec 8, 1995 | Substantially Equivalent |
| K950600 | VACUUM SURGE SUPRESSER | May 10, 1995 | Substantially Equivalent |
| K942945 | CASSETTE SYSTEM FOR STORZ | Dec 5, 1994 | Substantially Equivalent |
| K942944 | IRRIGATION/BIPOLAR SET | Sep 27, 1994 | Substantially Equivalent |
| K942897 | OPTHALMIC WIPE | Aug 5, 1994 | Substantially Equivalent |