FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS SCLEROTHERAPY BALLOON
K Number: K933992
·
Decision Dec 21, 1993
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
142
Review Days
126
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Basic Information
- Device Name
- OLYMPUS SCLEROTHERAPY BALLOON
- K Number
- K933992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Corp.
- Date Received
- August 17, 1993
- Decision Date
- December 21, 1993
- Product Code
- KNQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNQ | Dilator, Esophageal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNQ), ordered by most recent decision date.
CRE FIXED WIRE BALLON DILATION CATHETER
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FDA Class 2
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ETHICON ENDO-SURGERYOPTICAL DILATOR
FDA 510(k)
FDA Class 2
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HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMART DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Olympus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915402 | EW-10 AND EW-20 | Jun 23, 1995 | Substantially Equivalent for Some Indications |
| K933200 | OLYMPUS PBD STENTS | Apr 5, 1995 | Substantially Equivalent |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Nov 30, 1994 | Substantially Equivalent |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Aug 29, 1994 | Substantially Equivalent |
| K934835 | FLOVAL | Jun 21, 1994 | Substantially Equivalent |
| K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | Jun 8, 1994 | Substantially Equivalent |
| K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE | Mar 11, 1994 | Substantially Equivalent |
| K931994 | RESECTOSCOPE SHEATH | Feb 17, 1994 | Substantially Equivalent |
| K934361 | OLYMPUS CREATININE REAGENT | Nov 16, 1993 | Substantially Equivalent |
| K934136 | OLYMPUS CHLORIDE REAGENT, MODIFICATION | Nov 5, 1993 | Substantially Equivalent |