FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTURION CIRCLAMP
K Number: K890897
·
Decision Mar 28, 1989
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
16
Review Days
34
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Basic Information
- Device Name
- CENTURION CIRCLAMP
- K Number
- K890897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Tri-State Hospital Supply Corp.
- Date Received
- February 22, 1989
- Decision Date
- March 28, 1989
- Product Code
- HFX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFX | Clamp, Circumcision | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFX), ordered by most recent decision date.
Konig Bell Circumcision Clamp
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Circumplast Circumcision Device
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MALE CIRCUMCISION KITS:RAPIDECLAMP
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SHANGRING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Tri-State Hospital Supply Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Aug 28, 2008 | Substantially Equivalent |
| K080524 | CENTURION SORBAVIEW OTC | Apr 23, 2008 | Substantially Equivalent |
| K942353 | CENTURION UMBILICAL CATHETER | Aug 15, 1995 | Substantially Equivalent |
| K945977 | CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING | Mar 29, 1995 | Substantially Equivalent |
| K931748 | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS | Feb 25, 1994 | Unknown |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | Feb 17, 1994 | Substantially Equivalent |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | Dec 17, 1992 | Substantially Equivalent |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | Apr 1, 1991 | Substantially Equivalent |
| K897100 | CENTURION VAGINAL SPECULUM | Mar 16, 1990 | Substantially Equivalent |
| K896320 | CENTURION KLEEN-NEEDLE SYSTEM | Jan 11, 1990 | Substantially Equivalent |