Triangular Knife, Disposable #TM-1611
FDA 510(k) K873713 · Arthropedics, Inc.
510(k) numberK873713
Submission
- Device name
- Triangular Knife, Disposable #TM-1611
- 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
- HTS – Knife, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | Associated Medical Products Co. | 02/22/1994SE |
| K933921 | Acuflex Disposable KnivesHTS · Traditional | Acufex Microsurgical, Inc. | 01/26/1994SE |
| K882525 | Spinal MicroknifeHTS · Traditional | Karlin Technology, Inc. | 09/22/1988SE |
| K873714 | Banana Knife, Disposable #TM-1612HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873711 | Retrograde Knife, Disposable #TM-1613HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873712 | Standard Knife, Disposable #TM-1610HTS · Traditional | Arthropedics, Inc. | 10/15/1987SE |
| K842820 | Arthroscopy KnivesHTS · Traditional | Medtech Industries, Inc. | 08/14/1984SE |
| K771851 | Arthroscope Operative Knife SetHTS · Traditional | Richard Wolf Medical Instruments Corp. | 10/27/1977SE |
More from Richard Wolf Medical Instruments Corp.
| 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 |
| 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 Triangular Knife, Disposable #TM-1611 cleared by the FDA?
Triangular Knife, Disposable #TM-1611 (K873713) 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 K873713?
The FDA product code is HTS – Knife, Orthopedic, a Class I (low risk) device regulated under 21 CFR 888.4540.