Dobbhoff(R) Bipolar Hemostatic Probe
FDA 510(k) K912129 · Biosearch Medical Products, Inc.
510(k) numberK912129
Submission
- Device name
- Dobbhoff(R) Bipolar Hemostatic Probe
- Applicant
- Biosearch Medical Products, Inc.
Somerville, NJ, US - Received
- May 14, 1991
- Decision date
- August 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K260962 | SphincterotomeKNS · Traditional | Taewoong Medical Co., Ltd. | 05/21/2026SE |
| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
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| K951260 | Urinary Intermittent Catheters W/O Hydromer Hydrophilic LubricantKOD · Traditional | 09/27/1995SE |
| K944614 | Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemFDX · Traditional | 04/05/1995SE |
| K932295 | Non-Balloon Replacement Gastrostomy KitKNT · Traditional | 09/08/1994SE |
| K935045 | Biosearch Laproscopic Gastronomy CatheterKNT · Traditional | 08/19/1994SE |
| K923002 | Enteroclysis TubeKNT · Traditional | 06/28/1994SESK |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | 11/19/1993SE |
| K922987 | Lapstick Laparoscopic Sponge Stick/ Blunt Dissec.GCJ · Traditional | 04/23/1993SE |
Questions and answers
When was Dobbhoff(R) Bipolar Hemostatic Probe cleared by the FDA?
Dobbhoff(R) Bipolar Hemostatic Probe (K912129) received a 510(k) decision of Substantially Equivalent on August 7, 1991, 85 days after the submission was received.
What is the product code of K912129?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.