Arthroscope Operative Knife Set
FDA 510(k) K771851 · Richard Wolf Medical Instruments Corp.
510(k) numberK771851
Submission
- Device name
- Arthroscope Operative Knife Set
- Applicant
- Richard Wolf Medical Instruments Corp.
Mchenry, IL, US - Received
- September 29, 1977
- Decision date
- October 27, 1977
- 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 |
| K873713 | Triangular Knife, Disposable #TM-1611HTS · 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 |
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Questions and answers
When was Arthroscope Operative Knife Set cleared by the FDA?
Arthroscope Operative Knife Set (K771851) received a 510(k) decision of Substantially Equivalent on October 27, 1977, 28 days after the submission was received.
What is the product code of K771851?
The FDA product code is HTS – Knife, Orthopedic, a Class I (low risk) device regulated under 21 CFR 888.4540.