Bicap Ablating Forceps BAF-7
FDA 510(k) K884306 · Circon Acmi
510(k) numberK884306
Submission
- Device name
- Bicap Ablating Forceps BAF-7
- Applicant
- Circon Acmi
Stamford, CT, US - Received
- October 13, 1988
- Decision date
- January 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code KNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Creo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K013165 | USA Series LaparoscopesGCJ · Traditional | 01/18/2002SE |
| K980492 | AEH-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)FFK · Traditional | 11/17/1998SE |
| K905706 | GYN-1500 Hysteroscopic InufflatorHIG · Traditional | 02/28/1991SE |
| K905705 | Lap 3501 High Flow InsufflatorHIF · Traditional | 02/28/1991SE |
| K884097 | Morris Anti-Splatter Device for EndoscopesODC · Traditional | 04/17/1989SE |
| K884025 | Circon Acmi Bicap II Therapeutic System BC-200KNS · Traditional | 03/03/1989SE |
| K884254 | Circon Acmi Bicap III Therapeutic SystemKNS · Traditional | 01/11/1989SE |
| K884252 | Circon Acmi Bicap Hemorrhoid System BH-10 & BHP-20KNS · Traditional | 01/10/1989SE |
| K883819 | Bullard Intubating Laryngoscope Lar-A & Lar-PCCW · Traditional | 10/17/1988SE |
Questions and answers
When was Bicap Ablating Forceps BAF-7 cleared by the FDA?
Bicap Ablating Forceps BAF-7 (K884306) received a 510(k) decision of Substantially Equivalent on January 5, 1989, 84 days after the submission was received.
What is the product code of K884306?
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.