Monopolar Cautery Retrogade Tip #TM-1703
FDA 510(k) K873655 · Arthropedics, Inc.
510(k) numberK873655
Submission
- Device name
- Monopolar Cautery Retrogade Tip #TM-1703
- Applicant
- Arthropedics, Inc.
Wallington, NJ, US - Received
- September 10, 1987
- Decision date
- December 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOS – Electrode, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161600 | Resection ElectrodesJOS · Traditional | Olympus Winter & Ibe GmbH | 09/06/2016SE |
| K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorJOS · Traditional | Conmed Linvatec | 05/18/2005SE |
| K012684 | Reprocessed Electrosurgical ElectrodeJOS · Traditional | Sterilmed, Inc. | 01/18/2002SE |
| K011515 | Medline Grounding PadJOS · Traditional | Medline Industries, Inc. | 07/13/2001SE |
| K003403 | Endoscopic Monopolareectrode, Model Eme- 1000 to 1999JOS · Traditional | Highland / Marietta, Inc. | 05/07/2001SE |
| K000333 | Standard & Extended Blade, Standard & Extended Needle, Standard & Extended Ball…JOS · Traditional | Triad Surgical Technologies, Inc. | 05/03/2000SE |
| K993885 | Ultrablator ElectrodeJOS · Traditional | Linvatec Corp. | 02/10/2000SE |
| K991830 | Capsular Shrinkage ElectrodeJOS · Traditional | Linvatec Corp. | 08/20/1999SE |
| K974735 | Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade &…JOS · Traditional | Aaron Medical Industries | 06/24/1998SE |
| K973554 | Valley Forge Bipolar Ball Tip ElectrodeJOS · Traditional | Valley Forge Scientific Corp. | 12/19/1997SE |
More from Valley Forge Scientific Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K873619 | Arthroscopic Retention-Manipulation System (Arms)HRX · Traditional | 01/14/1988SE |
| K873654 | Monopolar Cautery Conical Tip #TM-1702JOS · Traditional | 12/15/1987SE |
| K873653 | Monopolar Cautery Blade Tip #TM-1701JOS · Traditional | 12/15/1987SE |
| K873387 | Video Arthroscope, 1.7MM X 55 MMHXR · Traditional | 11/25/1987SE |
| 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 Monopolar Cautery Retrogade Tip #TM-1703 cleared by the FDA?
Monopolar Cautery Retrogade Tip #TM-1703 (K873655) received a 510(k) decision of Substantially Equivalent on December 15, 1987, 96 days after the submission was received.
What is the product code of K873655?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.