Mmodification to Laminaria
FDA 510(k) K011512 · A & A Medical, Inc.
510(k) numberK011512
Submission
- Device name
- Mmodification to Laminaria
- Applicant
- A & A Medical, Inc.
Alpharetta, GA, US - Received
- May 16, 2001
- Decision date
- July 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HDY – Dilator, Cervical, Hygroscopic-Laminaria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040625 | Atad Ard CatheterHDY · Traditional | Atad Developments , Ltd. | 01/18/2005SE |
| K021012 | Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMHDY · Traditional | Quality Medical Solusions, LLC | 06/25/2002SE |
| K955072 | LaminariaHDY · Traditional | Cti Corp., Ltd. | 05/22/1996SE |
| K892220 | Laminaria TentHDY · Traditional | Berkeley Medevices | 06/14/1989SE |
| K881295 | Laminaria CurexHDY · Traditional | Harold W. Berger Co. | 08/10/1988SE |
| K881312 | LaminariaHDY · Traditional | Busse Hospital Disposables, Inc. | 05/23/1988SE |
| K880196 | LaminariaHDY · Traditional | Medgyn Products, Inc. | 05/06/1988SE |
| K845006 | Sun Medical Laminaria Cervical DilatorHDY · Traditional | Sun Medical, Inc. | 05/01/1985SE |
| K833068 | Laminaria Japonica Cervical DilatorHDY · Traditional | Medi-Spec | 02/04/1984SE |
| K782067 | Dilator, Mizutani Laminaria TentHDY · Traditional | British Marketing Ent., Ltd. | 01/03/1979SE |
More from British Marketing Ent., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K013491 | HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948LKF · Traditional | 11/19/2001SE |
| K013437 | SF SH Catheter, Model R65-945LKF · Traditional | 11/19/2001SE |
| K003949 | Tacker, Model R65-933OCW · Traditional | 07/25/2001SE |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1HET · Traditional | 05/16/2001SE |
| K010789 | Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2…GCJ · Traditional | 04/27/2001SE |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450LKF · Traditional | 02/01/2001SE |
| K000027 | Insufflation Needle, Model R65-933HIF · Traditional | 04/03/2000SE |
| K994256 | Suction Irrigation Trumpet Valve Set, Model Q65-823GCJ · Traditional | 02/03/2000SE |
| K974038 | The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene…JCX · Traditional | 05/11/1998SE |
| K974138 | Rocket ElectrodeHGI · Traditional | 01/30/1998SE |
Questions and answers
When was Mmodification to Laminaria cleared by the FDA?
Mmodification to Laminaria (K011512) received a 510(k) decision of Substantially Equivalent on July 9, 2001, 54 days after the submission was received.
What is the product code of K011512?
The FDA product code is HDY – Dilator, Cervical, Hygroscopic-Laminaria, a Class II (moderate risk) device regulated under 21 CFR 884.4260.