Kogan Endospeculum 9-1/2
FDA 510(k) K842111 · J. Sklar Mfg. Co., Inc.
510(k) numberK842111
Submission
- Device name
- Kogan Endospeculum 9-1/2
- Applicant
- J. Sklar Mfg. Co., Inc.
Mchenry, IL, US - Received
- May 29, 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 |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K841978 | Lateral Release Knife 5MM & 7MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
More from Stainless Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843693 | Jacobs High Vacuum Suction Unit 05-2570BTA · Traditional | 10/31/1984SE |
| K842112 | Tischler Cervical Biopsy Punch ForcepsHFB · Traditional | 07/03/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | 09/14/1982SE |
| K802458 | Kevorkian-Younge Biopsy Curette #90-6611HFB · Traditional | 01/12/1981SE |
| K802457 | Kevorkian-Younge Biopsy Punch, #90-6610HFB · Traditional | 01/12/1981SE |
| K801273 | Magill Catheter Intro. ForcepsKOA · Traditional | 07/28/1980SE |
| K800441 | Rudd-Clinic Hemorrhoidal ForcepsKOA · Traditional | 04/08/1980SE |
| K790577 | Hemorrhoidal LigatorHCF · Traditional | 04/23/1979SE |
| K772230 | Cannula, Perfusion, Fallopian TubeLKF · Traditional | 01/03/1978SE |
| K772229 | Miniclamps, Stabiliz., Fallopian TubeHCZ · Traditional | 01/03/1978SE |
Questions and answers
When was Kogan Endospeculum 9-1/2 cleared by the FDA?
Kogan Endospeculum 9-1/2 (K842111) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 21 days after the submission was received.
What is the product code of K842111?
The FDA product code is HTZ – Instrument, Cutting, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.