FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROCAUTERY SYSTEM MODEL 1980
K Number: K933079
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
20
Review Days
244
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Basic Information
- Device Name
- ELECTROCAUTERY SYSTEM MODEL 1980
- K Number
- K933079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pmt Corp.
- Date Received
- June 23, 1993
- Decision Date
- February 22, 1994
- Product Code
- HQP
- 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 |
|---|---|---|---|
| HQP | Unit, Cautery, Thermal, Battery-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQP), ordered by most recent decision date.
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F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
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STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
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FDA Class 2
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CAUTERY GRASPER/DISSECTOR
FDA 510(k)
FDA Class 2
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Other Clearances by Pmt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122376 | PMT TRUSCAN SURFACE ELECTRODE | Dec 19, 2012 | Substantially Equivalent |
| K090733 | PMT HALO SYSTEM | Jul 28, 2009 | Substantially Equivalent |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | May 8, 2009 | Substantially Equivalent |
| K042901 | ENDOMARK STERILE INDIA INK | Mar 16, 2005 | Substantially Equivalent |
| K033730 | PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES | Aug 3, 2004 | Substantially Equivalent |
| K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND | Oct 1, 1997 | Substantially Equivalent |
| K970418 | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) | Apr 29, 1997 | Substantially Equivalent |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | Mar 19, 1997 | Substantially Equivalent |
| K935560 | PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) | Nov 7, 1994 | Substantially Equivalent |
| K935499 | PMT SILICONE SHEETING | Feb 10, 1994 | Substantially Equivalent |