Video Arthroscope, 1.7MM X 55 MM
FDA 510(k) K873387 · Arthropedics, Inc.
510(k) numberK873387
Submission
- Device name
- Video Arthroscope, 1.7MM X 55 MM
- Applicant
- Arthropedics, Inc.
Wallington, NJ, US - Received
- June 26, 1987
- Decision date
- November 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXR – Spatula, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983882 | Micro Endoscope-Stainless Steel, Model MMD-1300, Micro Endoscope-Polyimide,Model MMD-1400HXR · Traditional | Micro-Medical Devices, Inc. | 03/15/1999SE |
| K872281 | Raylor Fusion FunnelHXR · Traditional | Cedar Surgical, Inc. | 11/02/1987SE |
| K853436 | H-H Hunter Passive Tendon ImplantHXR · Traditional | Holter-Hausner Intl. | 10/16/1985SE |
More from Holter-Hausner Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K873619 | Arthroscopic Retention-Manipulation System (Arms)HRX · Traditional | 01/14/1988SE |
| K873655 | Monopolar Cautery Retrogade Tip #TM-1703JOS · Traditional | 12/15/1987SE |
| K873654 | Monopolar Cautery Conical Tip #TM-1702JOS · Traditional | 12/15/1987SE |
| K873653 | Monopolar Cautery Blade Tip #TM-1701JOS · Traditional | 12/15/1987SE |
| K873714 | Banana Knife, Disposable #TM-1612HTS · Traditional | 11/02/1987SE |
| K873713 | Triangular Knife, Disposable #TM-1611HTS · Traditional | 11/02/1987SE |
| K873711 | Retrograde Knife, Disposable #TM-1613HTS · Traditional | 11/02/1987SE |
| K873710 | Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350HWB · Traditional | 11/02/1987SE |
| K873652 | Hook Probe #TM-1376HXB · Traditional | 11/02/1987SE |
| K873651 | Blunt Measuring Probe W/2MM Gradations #TM-1375HXB · Traditional | 11/02/1987SE |
Questions and answers
When was Video Arthroscope, 1.7MM X 55 MM cleared by the FDA?
Video Arthroscope, 1.7MM X 55 MM (K873387) received a 510(k) decision of Substantially Equivalent on November 25, 1987, 152 days after the submission was received.
What is the product code of K873387?
The FDA product code is HXR – Spatula, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.