510(k) K895800
- Device
- ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
- Applicant
- ADVANCED SURGICAL PRODUCTS, INC.
- 510(k) number
- K895800
- Product code
- HQR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-22
- Date received
- 1989-09-28
- Regulation
- 886.4100
- Classification name
- Apparatus, Cautery, Radiofrequency, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES C EASLEY
- Address
- 750 Goddard Ave. Chesterfield MO US 63005 63005
FDA Registration Numbers#
- 3015456951
- 3019924
- 3003398873
- 1450662
- 1649518
- 3033485955
- 1932402
- 1928237
- 3008692839
- 1644019
- 2523835
- 1319639
- 3008998256
- 3010047402
- 2029275
- 2028159
- 1319660
- 1650907
- 1643817
- 3005941719
- 3010208880
- 3029973819
- 9680660
- 9611665
- 3005012805
- 2126666
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050308 | THERMAL CAUTERY PROBE | Starion Instruments | 2005-02-25 |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Ophthalmic Technologies, Inc. | 1999-04-04 |
| K980522 | REFRACTEC MCS-100 | Refractec, Inc. | 1998-07-22 |
| K972749 | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | C.M. Chance , Ltd. | 1998-03-13 |
| K952151 | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | Storz | 1996-03-04 |
| K955158 | SURGITRON | Ellman Intl., Inc. | 1996-02-09 |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Gamp & Assoc. | 1996-01-05 |
| K941495 | RETURN PATH DIATHERMY HANDLE | Mira, Inc. | 1994-07-15 |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Mentor O & O, Inc. | 1994-02-16 |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | United Surgical Corp. | 1987-02-20 |
Legacy Summary#
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FDA Review#
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