Abdominal Pressure Control Valve
FDA 510(k) K844829 · L.A.S.E.R., Inc.
510(k) numberK844829
Submission
- Device name
- Abdominal Pressure Control Valve
- Applicant
- L.A.S.E.R., Inc.
Chicago, IL, US - Received
- December 12, 1984
- Decision date
- May 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHR – Laser, Surgical, Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4550
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K881507 | Endocoagulator Model 20 Laser & AccessoriesHHR · Traditional | Hgm Medical Laser Systems, Inc. | 04/27/1989SE |
| K871875 | Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional | Lasermatic, Inc. | 08/22/1988SE |
| K875314 | GL-35 Colposcopic Laser SystemHHR · Traditional | Laser Engineering, Inc. | 08/05/1988SE |
| K874615 | Laser Cannister FilterHHR · Traditional | Medical Marketing, Inc. | 06/23/1988SE |
| K880591 | Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional | Laser Peripherals, LLC | 06/01/1988SE |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LaseHHR · Traditional | Copper Lasersonics, Inc. | 05/31/1988SE |
| K880991 | Laser Optical Catheter SystemHHR · Traditional | Medline Industries, Inc. | 05/25/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | Cooper Lasersonics, Inc. | 03/24/1988SE |
| K874837 | KTP/532 Laser for Ob-Gyn UseHHR · Traditional | Laserscope | 03/14/1988SE |
| K875078 | Heracure LS 500HHR · Traditional | W.C. Heraeus GmbH | 02/22/1988SE |
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|---|---|---|
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| K940454 | Grasping Forceps, Punches, ScissorsHRX · Traditional | 03/25/1994SE |
| K931561 | Trocar SleeveHET · Traditional | 02/07/1994SE |
| K933421 | Endoscopic Instruments and AccessdoriesGCJ · Traditional | 11/02/1993SE |
| K924844 | Bulk Tissue Removal SystemHET · Traditional | 10/08/1993SE |
| K932045 | Disposable Insufflation TubingGCJ · Traditional | 09/23/1993SE |
| K931092 | Endoscopic RetractorGCJ · Traditional | 04/30/1993SE |
| K914197 | Alloy Scalpel HandpiecesGEX · Traditional | 04/10/1992SE |
| K904638 | Trocar DisposableFBQ · Traditional | 02/21/1991SE |
Questions and answers
When was Abdominal Pressure Control Valve cleared by the FDA?
Abdominal Pressure Control Valve (K844829) received a 510(k) decision of Substantially Equivalent on May 1, 1985, 140 days after the submission was received.
What is the product code of K844829?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.