Laparostat(Tm)
FDA 510(k) K913300 · Cook Ob/Gyn
510(k) numberK913300
Submission
- Device name
- Laparostat(Tm)
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- July 25, 1991
- Decision date
- April 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HAM – Apparatus, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153472 | Quiver Laparoscopic ExtendableHAM · Traditional | Itl Corporation Pty, Ltd. | 06/23/2016SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | Nikomed U.S.A., Inc. | 02/04/2000SE |
| K993306 | Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special | Paladin Medical, Inc. | 11/03/1999SE |
| K945861 | Bergen 710 EsuHAM · Traditional | Bergen Mfg. | 03/01/1995SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 02/03/1992SE |
| K911353 | Emc Model No. Statome 900HAM · Traditional | Emc Industries | 06/24/1991SE |
| K901248 | Abc Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 04/03/1990SE |
| K881334 | Light Coagulator LC 250HAM · Traditional | Nk-Optik GmbH | 11/16/1989SE |
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | New England Surgical Instrument Corp. | 09/15/1989SE |
| K894762 | B100 Disposable HandpieceHAM · Traditional | Beacon Laboratories, Inc. | 09/15/1989SE |
More from Beacon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | 10/27/2006SE |
| K030441 | Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitMQL · Traditional | 08/29/2003SE |
| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
| K983593 | Ovum Pick-Up Aspiration NeedlesMQE · Traditional | 01/21/1999SE |
Questions and answers
When was Laparostat(Tm) cleared by the FDA?
Laparostat(Tm) (K913300) received a 510(k) decision of Substantially Equivalent on April 2, 1992, 252 days after the submission was received.
What is the product code of K913300?
The FDA product code is HAM – Apparatus, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.