Apex Suction Curette
FDA 510(k) K871384 · Apex Medical, Inc.
510(k) numberK871384
Submission
- Device name
- Apex Suction Curette
- Applicant
- Apex Medical, Inc.
Martinsville, IN, US - Received
- April 7, 1987
- Decision date
- May 22, 1987
- 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
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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 |
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| K182394 | WiZARD 310/320 Series CPAP MaskBZD · Traditional | 05/17/2019SE |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesBZD · Traditional | 09/15/2015SE |
| K141522 | Apex Medical Corp. Ich CPAP with Pva 9S-007XXX SeriesBZD · Traditional | 10/06/2014SE |
| K121642 | Wizard 230 Nasal Pilow MaskBZD · Traditional | 06/06/2013SE |
| K112079 | Apex Medical XT Auto CPAP with Compliance Improvement Algorithm 9S-005720BZD · Traditional | 12/06/2012SE |
| K120035 | Apex Medical Ich CPAP Series (9S-007XXX)BZD · Special | 05/16/2012SE |
| K103174 | Apex Medical Wizard Series CPAP MaskBZD · Traditional | 05/06/2011SE |
| K103535 | Vacplus Suction UnitJCX · Traditional | 02/24/2011SE |
Questions and answers
When was Apex Suction Curette cleared by the FDA?
Apex Suction Curette (K871384) received a 510(k) decision of Substantially Equivalent on May 22, 1987, 45 days after the submission was received.
What is the product code of K871384?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.