FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K Number: K923847
·
Decision Nov 18, 1992
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
226
Applicant Total
91
Review Days
110
Basic Information
- Device Name
- DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
- K Number
- K923847
- 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
- WILSON-COOK MEDICAL, INC.
- Date Received
- July 31, 1992
- Decision Date
- November 18, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOQ), ordered by most recent decision date.
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
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FDA Class 2
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FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
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FDA Class 2
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Disposable Balloon Catheter B5-2C
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Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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.
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by WILSON-COOK MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K161203 | Soehendra Stent Retriever | May 4, 2016 | Substantially Equivalent |
| K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON | Jul 19, 2010 | Substantially Equivalent |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | Jan 5, 2007 | Substantially Equivalent |
| K052051 | OMNI SPHINCTEROTOME | Aug 5, 2005 | Substantially Equivalent |
| K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE | May 11, 2005 | Substantially Equivalent |
| K040930 | ZILVER BILIARY STENT SYSTEM USW | Jul 2, 2004 | Unknown |
| K040800 | WILOSN-COOK BILIARY DILATION BALLOON | Jun 25, 2004 | Substantially Equivalent |