FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CAVERMAP SURGICAL AID
K Number: K010098
·
Decision Feb 1, 2001
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
6
Applicant Total
10
Review Days
21
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Basic Information
- Device Name
- MODIFICATION TO CAVERMAP SURGICAL AID
- K Number
- K010098
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Uromed Corp.
- Date Received
- January 11, 2001
- Decision Date
- February 1, 2001
- Product Code
- FGM
- 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 |
|---|---|---|---|
| FGM | Probe And Director, Gastro-Urology | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGM), ordered by most recent decision date.
CAVERMAP SURGICAL AID
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MODIFICATION TO CAVERMAP SURGICAL AID
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ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG
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ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
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ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG
FDA 510(k)
FDA Class 1
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Other Clearances by Uromed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K010213 | MODIFICATION TO CAVERMAP SURGICAL AID | Apr 20, 2001 | Substantially Equivalent |
| K000507 | CAVERMAP SURGICAL AID | Apr 21, 2000 | Substantially Equivalent |
| K993436 | CAVERMAP SURGICAL AID | Feb 11, 2000 | Substantially Equivalent |
| K982226 | UROMED BRACHYTHERAPHY IODINE-125 SOURCES | May 13, 1999 | Substantially Equivalent |
| K980717 | UROMED SLING KIT | May 22, 1998 | Substantially Equivalent |
| K974600 | UROMED PATCH | Mar 31, 1998 | Substantially Equivalent |
| K974137 | UROMED NEEDLE GRASPER | Jan 30, 1998 | Substantially Equivalent |
| K970971 | URO MED NERVE STIMULATOR | Oct 27, 1997 | Substantially Equivalent |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Aug 1, 1997 | Substantially Equivalent |