Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350
FDA 510(k) K873710 · Arthropedics, Inc.
510(k) numberK873710
Submission
- Device name
- Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350
- Applicant
- Arthropedics, Inc.
Wallington, NJ, US - Received
- September 15, 1987
- Decision date
- November 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWB – Extractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870844 | Schultz Prosthesis Component Inserter ExtractorHWB · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
| K870083 | Ferray ExtractorHWB · Traditional | Terray Manufacturing, Inc. | 02/26/1987SE |
| K801327 | The Extractor I TMHWB · Traditional | The Anspach Effort, Inc. | 06/09/1980SE |
| K780300 | Hip Plate Removal InstrumentHWB · Traditional | Richard'S Medical Equip., Inc. | 02/28/1978SE |
More from Richard'S Medical Equip., Inc.
| 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 |
| 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 |
| 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 Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350 cleared by the FDA?
Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350 (K873710) received a 510(k) decision of Substantially Equivalent on November 2, 1987, 48 days after the submission was received.
What is the product code of K873710?
The FDA product code is HWB – Extractor, a Class I (low risk) device regulated under 21 CFR 888.4540.