Surgical Dynamics Nucleotome II Tissue Aspir/Cuter
FDA 510(k) K902778 · Surgical Dynamics, Inc.
510(k) numberK902778
Submission
- Device name
- Surgical Dynamics Nucleotome II Tissue Aspir/Cuter
- Applicant
- Surgical Dynamics, Inc.
Mountain View, CA, US - Received
- June 25, 1990
- Decision date
- October 30, 1990
- Decision
- Substantially Equivalent (SESE)
- 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).
Other 510(k)s with product code HRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K960046 | Surgical Dynamics 30K Working Channel ScopeHRX · Traditional | 04/02/1996SE |
| K942987 | Nucleotome L KitGET · Traditional | 10/30/1995SE |
| K954193 | Surgical Dynamics 30K Working Channel Scope & Instrument SetHRX · Traditional | 10/23/1995SE |
| K950495 | Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000BTA · Traditional | 05/09/1995SE |
| K931109 | Nucleotome E KitHRX · Traditional | 03/29/1994SN |
| K921950 | Surgical Dynamics Discography SystemFMI · Traditional | 06/07/1993SEKD |
| K923525 | Nucleotome 3.5 MM Automated Percutaneous LumbarHRX · Traditional | 02/09/1993SE |
| K914282 | Nucleotome(R) II (VERSION2) Tissue Aspira/CutterHRX · Traditional | 12/19/1991SE |
| K913145 | Nucleotome Tissue Aspirator/CutterHRX · Traditional | 12/19/1991SE |
| K894336 | Surgical Dynamics Discography System · Traditional | 08/04/1989SEKD |
Questions and answers
When was Surgical Dynamics Nucleotome II Tissue Aspir/Cuter cleared by the FDA?
Surgical Dynamics Nucleotome II Tissue Aspir/Cuter (K902778) received a 510(k) decision of Substantially Equivalent on October 30, 1990, 127 days after the submission was received.
What is the product code of K902778?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.