FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
K Number: K895800
·
Decision Jan 22, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
10
Applicant Total
64
Review Days
116
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Basic Information
- Device Name
- ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
- K Number
- K895800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Surgical Products, Inc.
- Date Received
- September 28, 1989
- Decision Date
- January 22, 1990
- Product Code
- HQR
- 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 |
|---|---|---|---|
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQR), ordered by most recent decision date.
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PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
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SURGITRON
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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 |
| K896754 | I/A HANDPIECE | Jan 11, 1990 | Substantially Equivalent |
| K896305 | MULTI-USE I/A HANDPIECE | Dec 18, 1989 | Substantially Equivalent |
| K884557 | ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE | May 12, 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 |