CENTURION CIRCLAMP
FDA 510(k) clearance K890897 · decided 1989-03-28
Clearance details
- K-number
- K890897
- Device name
- CENTURION CIRCLAMP
- Applicant
- Tri-State Hospital Supply Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-22
- Decision date
- 1989-03-28
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- HFX
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Howell, MI, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Konig Bell Circumcision Clamp (K251687) | Medline Industries, LP | 2026-02-25 |
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| Circumplast Circumcision Device (K151095) | Novadien Healthcare | 2015-09-18 |
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| SHANGRING (K131373) | Wuhu Snnda Medical Treatment Appliance Technology | 2013-06-25 |
| SHANGRING (K121789) | Wuhu Snna Medical Treatment Appliance Technology C | 2012-08-03 |
| PREPEX SYSTEM (K103695) | Circ Medtech | 2012-01-10 |
| MEDICON MOGEN CLAMP (K100916) | Medicon EG | 2010-12-06 |
| GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (K061539) | Clinical Innovations, LLC | 2007-09-20 |
| GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (K063429) | Generic Medical Device, Inc. | 2007-01-17 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and recall (Z-0133-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2024-10-18 |
| Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 1 recall (Z-2649-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-09-29 |
| Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile. recall (Z-1407-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-04-19 |
| Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330. recall (Z-0836-05) | Tri-State Hospital Supply Corp | 2005-05-12 |
| Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310. recall (Z-0837-05) | Tri-State Hospital Supply Corp | 2005-05-12 |