Laminaria
FDA 510(k) K881312 · Busse Hospital Disposables, Inc.
510(k) numberK881312
Submission
- Device name
- Laminaria
- Applicant
- Busse Hospital Disposables, Inc.
Hauppauge, NY, US - Received
- March 28, 1988
- Decision date
- May 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K011512 | Mmodification to LaminariaHDY · Traditional | A & A Medical, Inc. | 07/09/2001SE |
| 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 |
| 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 |
|---|---|---|
| K141285 | Busse Extension SetFPA · Traditional | 02/19/2015SE |
| K120002 | I-Style Bone Marrow Aspiration Needle with T-HandleKNW · Traditional | 06/26/2012SE |
| K110883 | J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition CannulaKNW · Traditional | 06/08/2011SE |
| K093920 | Busse Epidural Catheter KitBSO · Traditional | 08/06/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | 05/06/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | 10/09/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | 12/09/2008SE |
| K073222 | Modification To:Specialty NeedlesBSP · Special | 04/09/2008SE |
| K070465 | Busse Epidural CatheterBSO · Traditional | 07/19/2007SE |
| K063018 | Glass Loss of Resistance SyringeCAZ · Traditional | 01/22/2007SE |
Questions and answers
When was Laminaria cleared by the FDA?
Laminaria (K881312) received a 510(k) decision of Substantially Equivalent on May 23, 1988, 56 days after the submission was received.
What is the product code of K881312?
The FDA product code is HDY – Dilator, Cervical, Hygroscopic-Laminaria, a Class II (moderate risk) device regulated under 21 CFR 884.4260.