FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K Number: K884557
·
Decision May 12, 1989
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
64
Review Days
193
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Basic Information
- Device Name
- ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
- K Number
- K884557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Surgical Products, Inc.
- Date Received
- October 31, 1988
- Decision Date
- May 12, 1989
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Advanced Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030926 | FAST THROW STAINLESS STEEL SURGICAL SUTURE | Jul 21, 2003 | Substantially Equivalent |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Jan 22, 1990 | Substantially Equivalent |
| K896754 | I/A HANDPIECE | Jan 11, 1990 | Substantially Equivalent |
| K896305 | MULTI-USE I/A HANDPIECE | Dec 18, 1989 | Substantially Equivalent |
| K884556 | DREYER CURVED ENDOILLUMINATOR | Feb 28, 1989 | Substantially Equivalent |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Feb 17, 1989 | Substantially Equivalent |
| K884347 | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN | Dec 27, 1988 | Substantially Equivalent |
| K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |
| K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |
| K883856 | FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |