FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
K Number: K993900
·
Decision Jan 28, 2000
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
226
Applicant Total
11
Review Days
73
Basic Information
- Device Name
- COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
- K Number
- K993900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BRONCUS TECHNOLOGIES, INC.
- Date Received
- November 16, 1999
- Decision Date
- January 28, 2000
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US
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InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.
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Other Clearances by BRONCUS TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K112051 | LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE | Oct 12, 2011 | Substantially Equivalent |
| K093423 | LUNGPOINT PROCEDURE PLANNING | Nov 17, 2009 | Substantially Equivalent |
| K091160 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | May 5, 2009 | Substantially Equivalent |
| K090853 | YIELD TISSUE SAMPLER | Apr 7, 2009 | Substantially Equivalent |
| K090743 | YIELD MINI DOPPLER SYSTEM | Apr 3, 2009 | Substantially Equivalent |
| K090095 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | Mar 13, 2009 | Substantially Equivalent |
| K013111 | EXHALE PROBE | Oct 1, 2001 | Substantially Equivalent |
| K011267 | EXHALE RF PROBE | May 8, 2001 | Substantially Equivalent |
| K010649 | EXHALE DOPPLER SYSTEM | Mar 20, 2001 | Substantially Equivalent |
| K980046 | BRONCHIAL CATHETER SYSTEM | May 1, 1998 | Substantially Equivalent |