FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K Number: K862000
·
Decision Aug 12, 1986
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
29
Review Days
81
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Basic Information
- Device Name
- KEYMED FLEXIBLE ESOPHAGEAL DILATORS
- K Number
- K862000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Keymed, Inc.
- Date Received
- May 23, 1986
- Decision Date
- August 12, 1986
- 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.
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COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
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MAXFORCE TTS SINGLE-USE BALLOON DILATOR
FDA 510(k)
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Other Clearances by Keymed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Apr 22, 2010 | Substantially Equivalent |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Mar 29, 1993 | Substantially Equivalent |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | May 12, 1988 | Substantially Equivalent |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Feb 12, 1987 | Substantially Equivalent |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | Dec 24, 1986 | Substantially Equivalent |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Jul 15, 1986 | Substantially Equivalent |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Jun 23, 1986 | Substantially Equivalent |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | Jun 17, 1986 | Substantially Equivalent |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Nov 26, 1985 | Substantially Equivalent |
| K854304 | KEYMED OFFICE COUCH | Nov 12, 1985 | Substantially Equivalent |