FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITRON
K Number: K955158
·
Decision Feb 9, 1996
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
10
Applicant Total
15
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGITRON
- K Number
- K955158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ellman Intl., Inc.
- Date Received
- November 13, 1995
- Decision Date
- February 9, 1996
- 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.
THERMAL CAUTERY PROBE
FDA 510(k)
FDA Class 2
·Ophthalmic
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
REFRACTEC MCS-100
FDA 510(k)
FDA Class 2
·Ophthalmic
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
FDA 510(k)
FDA Class 2
·Ophthalmic
STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
FDA 510(k)
FDA Class 2
·Ophthalmic
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Ellman Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013255 | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF | Nov 7, 2001 | Substantially Equivalent |
| K003126 | BIPOLAR TRIGGER-FLEX PROBE | Apr 11, 2001 | Substantially Equivalent |
| K001986 | SURGITRON IEC II | Sep 27, 2000 | Substantially Equivalent |
| K001407 | SURGITRON IEC II | Jul 24, 2000 | Substantially Equivalent |
| K001253 | SURGITRON IEC II | May 26, 2000 | Substantially Equivalent |
| K992382 | SURGITRON RADIOLASE | Oct 14, 1999 | Substantially Equivalent |
| K990146 | SURGITRON | Mar 17, 1999 | Substantially Equivalent |
| K980177 | SUGITRON MODEL: IEC | Jul 7, 1998 | Substantially Equivalent |
| K980170 | SURGITRON | Jun 29, 1998 | Substantially Equivalent |
| K972072 | SURGITRON MODEL FFPF-EMC | Jun 19, 1997 | Substantially Equivalent |