Medicalex
FDA 510(k) K833377 · Medicalex
510(k) numberK833377
Submission
- Device name
- Medicalex
- Applicant
- Medicalex
Walker, MI, US - Received
- September 29, 1983
- Decision date
- September 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003965 | MRI Safe InstrumentsGEA · Traditional | Aesculap, Inc. | 03/16/2001SE |
| K982472 | Genicon TrocarGEA · Traditional | Genicon, LC | 02/04/1999SE |
| K954599 | Conmed Trogard Electronic Trocar SystemGEA · Traditional | Conmedcorp | 11/27/1995SE |
| K922460 | Origin Secondary Cannula and TrocarGEA · Traditional | Origin Medsystems, Inc. | 09/16/1992SE |
| K920110 | Endopath Disposable Thoracic Trocar SleeveGEA · Traditional | ETHICON, Inc. | 04/02/1992SE |
| K911262 | Disposable Specimen Bag W/Cannula and IntroducerGEA · Traditional | ETHICON, Inc. | 06/20/1991SE |
| K904881 | Disposable Yankauer Suction TubeGEA · Traditional | Pilling Medical S.A. | 03/06/1991SE |
| K903416 | Cannula, SurgicalGEA · Traditional | Advantage Diagnostics Corp. | 11/23/1990SE |
| K904218 | Suction SystemGEA · Traditional | Axiom Medical, Inc. | 10/31/1990SE |
| K901718 | Klein Lamprey-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
More from Jeff Klein Surgical, Inc.
Questions and answers
When was Medicalex cleared by the FDA?
Medicalex (K833377) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 364 days after the submission was received.
What is the product code of K833377?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.