BAXTER DISPOSABLE CIRCUMCISION TRAY
FDA 510(k) clearance K884290 · decided 1988-12-08
Clearance details
- K-number
- K884290
- Device name
- BAXTER DISPOSABLE CIRCUMCISION TRAY
- Applicant
- Baxter Healthcare Corp
- Decision
- Unknown
- Date received
- 1988-10-12
- Decision date
- 1988-12-08
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- HFX
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Niles, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Konig Bell Circumcision Clamp (K251687) | Medline Industries, LP | 2026-02-25 |
| Wee Bell (K221356) | Wee Medical | 2023-02-02 |
| Konig Mogen Clamp (K212911) | Medline Industries, Inc. | 2022-11-18 |
| Circumplast Circumcision Device (K151095) | Novadien Healthcare | 2015-09-18 |
| MALE CIRCUMCISION KITS:RAPIDECLAMP (K142163) | Medicfit Technology Sdn Bhd | 2015-04-20 |
| 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 |
| SURGICAL DESIGN CIRCUMCISION CLAMP (K043533) | Surgical Design, Inc. | 2005-04-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |