Shepperd Cutting Forceps
FDA 510(k) K900616 · Downs Surgical , Ltd.
510(k) numberK900616
Submission
- Device name
- Shepperd Cutting Forceps
- Applicant
- Downs Surgical , Ltd.
Sheffield S9 4wj, GB - Received
- February 8, 1990
- Decision date
- October 22, 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 |
|---|---|---|
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | 10/31/1990SE |
| K903748 | Islam Sternal Puncture Needle, Cat # AF-594-00-VGDM · Traditional | 10/31/1990SE |
| K903747 | Islam Sternal Puncture Needle, Cat # AG-592-00-UGDM · Traditional | 10/31/1990SE |
| K900615 | Shepperd Nerve Root Retractor W/Suction & FibreHRX · Traditional | 10/22/1990SE |
| K900614 | Shepperd Short Muscle Retractor (GS-501-45-V)HRX · Traditional | 10/22/1990SE |
| K900613 | Shepperd Shelter Tube Complete & DrillHRX · Traditional | 10/22/1990SE |
| K900612 | Shepperd Trephine Set (GS-501-30-V)HRX · Traditional | 10/22/1990SE |
| K900611 | Shepperd Dilatation Tube Set (GS-501-20-H)HRX · Traditional | 10/22/1990SE |
| K900610 | Shepperd Cannula Stillette & Obdurator SetHRX · Traditional | 10/22/1990SE |
Questions and answers
When was Shepperd Cutting Forceps cleared by the FDA?
Shepperd Cutting Forceps (K900616) received a 510(k) decision of Substantially Equivalent on October 22, 1990, 256 days after the submission was received.
What is the product code of K900616?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.