LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
FDA 510(k) clearance K021012 · decided 2002-06-25
Clearance details
- K-number
- K021012
- Device name
- LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
- Applicant
- Quality Medical Solusions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-03-29
- Decision date
- 2002-06-25
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HDY
- Device class
- 2
- Regulation number
- 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Alpharetta, GA, 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 |
|---|---|---|
| ATAD ARD CATHETER (K040625) | Atad Developments , Ltd. | 2005-01-18 |
| MMODIFICATION TO LAMINARIA (K011512) | A & A Medical, Inc. | 2001-07-09 |
| LAMINARIA (K955072) | Cti Corp., Ltd. | 1996-05-22 |
| LAMINARIA TENT (K892220) | Berkeley Medevices | 1989-06-14 |
| LAMINARIA CUREX (K881295) | Harold W. Berger Co. | 1988-08-10 |
| LAMINARIA (K881312) | Busse Hospital Disposables, Inc. | 1988-05-23 |
| LAMINARIA (K880196) | Medgyn Products, Inc. | 1988-05-06 |
| SUN MEDICAL LAMINARIA CERVICAL DILATOR (K845006) | Sun Medical, Inc. | 1985-05-01 |
| LAMINARIA JAPONICA CERVICAL DILATOR (K833068) | Medi-Spec | 1984-02-04 |
| DILATOR, MIZUTANI LAMINARIA TENT (K782067) | British Marketing Ent., Ltd. | 1979-01-03 |
Recalls involving this device
No recalls on record reference this clearance.