Endo-Bend(Tm) Shaver
FDA 510(k) K950054 · Paladin Medical, Inc.
510(k) numberK950054
Submission
- Device name
- Endo-Bend(Tm) Shaver
- Applicant
- Paladin Medical, Inc.
Stillwater, MN, US - Received
- January 6, 1995
- Decision date
- June 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
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| 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 |
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Questions and answers
When was Endo-Bend(Tm) Shaver cleared by the FDA?
Endo-Bend(Tm) Shaver (K950054) received a 510(k) decision of Substantially Equivalent on June 29, 1995, 174 days after the submission was received.
What is the product code of K950054?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.