BAXTER D & C TRAY
FDA 510(k) clearance K901442 · decided 1990-07-26
Clearance details
- K-number
- K901442
- Device name
- BAXTER D & C TRAY
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-03-27
- Decision date
- 1990-07-26
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- HCY
- Device class
- 1
- 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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| OAC (OPTICAL ASPIRATING CURETTE) (K980096) | Imagyn Medical Technologies, Inc. | 1998-05-01 |
| ENDOCYTE TM (K944238) | D.L. Nelson and Assoc., Inc. | 1995-09-15 |
| PHASE I CURETTE (K935822) | Phase I Corp. | 1994-04-28 |
| UTERINE CURETTE (K890384) | Kinetic Medical Products | 1989-02-13 |
| IVORY FINDER SET (K881794) | Ivory Instruments Co. | 1988-07-08 |
| THE D & C PAD-SAC (K862297) | Nu-Gyn-Tek, Inc. | 1986-07-07 |
| LUNE AU CURETTES (K850068) | Luneau Laboratories | 1985-04-08 |
| SURGICAL CURETTE, VARIOUS (K841004) | Premier Dental Products Co. | 1984-05-11 |
| UTERINE CURETTE (K802313) | Gynemetrics, Inc. | 1981-01-12 |
| DISPOSABLE VACUUM CURETTE (K790032) | British Marketing Ent., Ltd. | 1979-02-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical p recall (Z-1402-2016) | Customed, Inc | 2016-04-14 |
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 |