Soft Suction Adapter
FDA 510(k) K895684 · Applied Medical Technologies
510(k) numberK895684
Submission
- Device name
- Soft Suction Adapter
- Applicant
- Applied Medical Technologies
Independence, OH, US - Received
- September 21, 1989
- Decision date
- November 20, 1989
- 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
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|---|---|---|---|
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceKNT · Traditional | 08/17/1998SE |
| K972478 | Pre-Loaded Replacement G-Tubes and AccessoriesKNT · Traditional | 02/09/1998SE |
| K973893 | Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring…KNT · Traditional | 12/19/1997SE |
| K971757 | Low Profile Feeding Set AccessoryKNT · Traditional | 11/07/1997SE |
| K971758 | Cauterization Smoke EvacuatorGEI · Traditional | 07/21/1997SE |
| K961345 | Domed Percutaneous Endoscopic Gastrostomy(P.E.G.) Feeding TubeKNT · Traditional | 09/17/1996SE |
| K960232 | Endoscopic Access DeviceGCJ · Traditional | 03/21/1996SE |
| K945618 | Gastrointestinal Tubes & AccessoriesKNT · Traditional | 10/12/1995SE |
| K946140 | PRG ButtonKNT · Traditional | 08/28/1995SE |
| K923488 | Gastranimal Percutaneous Replacement GastroomyKNT · Traditional | 07/20/1995SE |
Questions and answers
When was Soft Suction Adapter cleared by the FDA?
Soft Suction Adapter (K895684) received a 510(k) decision of Substantially Equivalent on November 20, 1989, 60 days after the submission was received.
What is the product code of K895684?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.