Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe
FDA 510(k) K944861 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK944861
Submission
- Device name
- Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- October 3, 1994
- Decision date
- February 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
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| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
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| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
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Questions and answers
When was Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe cleared by the FDA?
Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe (K944861) received a 510(k) decision of Substantially Equivalent on February 21, 1995, 141 days after the submission was received.
What is the product code of K944861?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.