FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JESBERG ESOPHAGOSCOPE
K Number: K892259
·
Decision Jun 16, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
76
Review Days
73
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Basic Information
- Device Name
- JESBERG ESOPHAGOSCOPE
- K Number
- K892259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4710
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Date Received
- April 4, 1989
- Decision Date
- June 16, 1989
- Product Code
- EOX
- 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 |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOX), ordered by most recent decision date.
EndoSign® Cell collection device (ES-CYT-102)
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EsoCheck Cell Collection Device
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PENTAX Medical Video Esophagoscope EE17-J10
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EsoCheck Cell Collection Device
FDA 510(k)
FDA Class 2
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EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EsoCheck Cell Collection Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Zinnanti Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925501 | NYLON COATED SPECULA | Jun 13, 1997 | Substantially Equivalent |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | Jan 25, 1995 | Substantially Equivalent |
| K941457 | UTERINE INJECTOR WITH SPRING | Jan 24, 1995 | Substantially Equivalent |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | Aug 30, 1994 | Substantially Equivalent |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Apr 7, 1994 | Substantially Equivalent |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | Mar 24, 1994 | Substantially Equivalent |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Dec 17, 1993 | Substantially Equivalent |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | Nov 12, 1993 | Substantially Equivalent |