Videoscope W/Irrigation Sheath
FDA 510(k) K954016 · T. Korossurgical Instruments Corp.
510(k) numberK954016
Submission
- Device name
- Videoscope W/Irrigation Sheath
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- August 25, 1995
- Decision date
- January 25, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
More from Hand Biomechanics Lab, Inc.
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| K001915 | Graft Marker RingMAB · Traditional | 04/27/2001SE |
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| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
| K954052 | Arthroscopic Grasper, Cup Forceps and CurettesHRX · Traditional | 11/06/1995SN |
| K954014 | Percutaneous Discectomy Cannula SystemHRX · Traditional | 11/06/1995SN |
| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | 03/22/1994SE |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | 08/06/1993SE |
| K926583 | Reusable Endoscopic Scissors, Grasper-MonopolarGCJ · Traditional | 08/06/1993SE |
| K931259 | Endoscopic or Thorascopic ForcepsGCJ · Traditional | 06/08/1993SE |
Questions and answers
When was Videoscope W/Irrigation Sheath cleared by the FDA?
Videoscope W/Irrigation Sheath (K954016) received a 510(k) decision of Substantially Equivalent for Some Indications on January 25, 1996, 153 days after the submission was received.
What is the product code of K954016?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.