FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
K Number: K945171
·
Decision Feb 8, 1995
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
17
Review Days
110
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Basic Information
- Device Name
- DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
- K Number
- K945171
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boston Surgical Products, Inc.
- Date Received
- October 21, 1994
- Decision Date
- February 8, 1995
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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Other Clearances by Boston Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972311 | MODEL 20 BIPOLAR COAGULATOR | Sep 18, 1997 | Substantially Equivalent |
| K972350 | MODEL 50 BIPOLAR COAGULATOR | Aug 21, 1997 | Substantially Equivalent |
| K944947 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS | Jul 28, 1995 | Substantially Equivalent |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | Jul 12, 1995 | Substantially Equivalent |
| K950375 | DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR | Jun 14, 1995 | Substantially Equivalent |
| K951912 | DISOPOSABLE & RESUABLE MONPOLAR CORD | May 12, 1995 | Substantially Equivalent |
| K951269 | DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL | Apr 24, 1995 | Substantially Equivalent |
| K950877 | REUSABLE MONOPOLAR FORCEPS | Mar 9, 1995 | Substantially Equivalent |
| K945893 | DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE | Dec 13, 1994 | Substantially Equivalent |
| K944634 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Dec 8, 1994 | Substantially Equivalent |