Concept Suction Sleeve
FDA 510(k) K850423 · Concept, Inc.
510(k) numberK850423
Submission
- Device name
- Concept Suction Sleeve
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- February 4, 1985
- Decision date
- March 14, 1985
- 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
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| 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 |
| 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 |
| K841978 | Lateral Release Knife 5MM & 7MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
More from Stainless Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
| K912957 | Concept MicromillHRX · Traditional | 10/04/1991SE |
| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Concept Suction Sleeve cleared by the FDA?
Concept Suction Sleeve (K850423) received a 510(k) decision of Substantially Equivalent on March 14, 1985, 38 days after the submission was received.
What is the product code of K850423?
The FDA product code is HTZ – Instrument, Cutting, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.