Codman Suction Punch-Product Codes
FDA 510(k) K842774 · Codman & Shurtleff, Inc.
510(k) numberK842774
Submission
- Device name
- Codman Suction Punch-Product Codes
- Applicant
- Codman & Shurtleff, Inc.
Walker, MI, US - Received
- July 16, 1984
- Decision date
- July 27, 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 |
| 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 |
| K841978 | Lateral Release Knife 5MM & 7MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K191237 | CERENOVUS Large Bore CatheterDQY · Traditional | 11/08/2019SE |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special | 11/08/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | 07/14/2017SE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special | 07/03/2017SE |
| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was Codman Suction Punch-Product Codes cleared by the FDA?
Codman Suction Punch-Product Codes (K842774) received a 510(k) decision of Substantially Equivalent on July 27, 1984, 11 days after the submission was received.
What is the product code of K842774?
The FDA product code is HTZ – Instrument, Cutting, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.