Rosette Knife 4MM
FDA 510(k) K841975 · Stainless Mfg., Inc.
510(k) numberK841975
Submission
- Device name
- Rosette Knife 4MM
- Applicant
- Stainless Mfg., Inc.
Mchenry, IL, US - Received
- May 14, 1984
- Decision date
- June 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTZ – Instrument, Cutting, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933933 | CeboplaneHTZ · Traditional | Synvasive Technology, Inc. | 04/15/1994SE |
| K931737 | Hedleyl Intramedullary Preparation BrushHTZ · Traditional | Synvasive Technology, Inc. | 01/07/1994SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | Bowen & Company, Inc. | 03/23/1987SE |
| K853678 | Kambin Spinal Instrument SetHTZ · Traditional | Pilling Co. | 09/24/1985SE |
| K850527 | Arthroscopy Suction Biopsy PunchHTZ · Traditional | T. Korossurgical Instruments Corp. | 03/14/1985SE |
| K850423 | Concept Suction SleeveHTZ · Traditional | Concept, Inc. | 03/14/1985SE |
| K841980 | Side Cutting Serrated BladeHTZ · Traditional | Stainless Mfg., Inc. | 08/15/1984SE |
| K842774 | Codman Suction Punch-Product CodesHTZ · Traditional | Codman & Shurtleff, Inc. | 07/27/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | J. Sklar Mfg. Co., Inc. | 06/19/1984SE |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
More from Stainless Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841980 | Side Cutting Serrated BladeHTZ · Traditional | 08/15/1984SE |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | 06/19/1984SE |
| K841981 | 4MM & 5MM FileHTP · Traditional | 06/19/1984SE |
| K841979 | 4MM Cup CurretteHTF · Traditional | 06/19/1984SE |
| K841978 | Lateral Release Knife 5MM & 7MMHTZ · Traditional | 06/19/1984SE |
| K841977 | 5MM Dougle Edge Ring CuretteHTZ · Traditional | 06/19/1984SE |
| K841976 | Hook Knife 4MM & 5MMHTZ · Traditional | 06/19/1984SE |
| K841974 | Retrograde Knife 4MM & 5MMHTZ · Traditional | 06/19/1984SE |
| K841973 | Banana Knife SerratedHTZ · Traditional | 06/19/1984SE |
| K841972 | Banana Knife - K841969-LABELINGHTZ · Traditional | 06/19/1984SE |
Questions and answers
When was Rosette Knife 4MM cleared by the FDA?
Rosette Knife 4MM (K841975) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 36 days after the submission was received.
What is the product code of K841975?
The FDA product code is HTZ – Instrument, Cutting, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.