Suction Tube Tip Fits Over Bussie Frazier Tube
FDA 510(k) K872906 · American Silk Sutures, Inc.
510(k) numberK872906
Submission
- Device name
- Suction Tube Tip Fits Over Bussie Frazier Tube
- Applicant
- American Silk Sutures, Inc.
Lynn, MA, US - Received
- July 24, 1987
- Decision date
- August 11, 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 |
More from Jeff Klein Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922143 | American Burn SheetKME · Traditional | 08/10/1992SE |
| K904514 | Strung Telfa Non-Adherent SpongeHBA · Traditional | 03/27/1991SE |
| K902921 | Rayon Neurological SpongeHBA · Traditional | 09/18/1990SE |
| K872810 | Strung Dental RollsEFN · Traditional | 12/04/1987SE |
| K872951 | American Brain Retractor CoverGET · Traditional | 09/16/1987SE |
| K872905 | American Nasal SpongeEPP · Traditional | 09/04/1987SE |
| K872809 | Gauze Cherry SpongeGDY · Traditional | 08/04/1987SE |
| K872808 | Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8EFQ · Traditional | 08/04/1987SE |
| K872807 | Non-Woven Tracheotomy SpongeGDY · Traditional | 08/04/1987SE |
| K872806 | Stick Sponge, Strung Tonsil Sponge Double StrungEFQ · Traditional | 08/04/1987SE |
Questions and answers
When was Suction Tube Tip Fits Over Bussie Frazier Tube cleared by the FDA?
Suction Tube Tip Fits Over Bussie Frazier Tube (K872906) received a 510(k) decision of Substantially Equivalent on August 11, 1987, 18 days after the submission was received.
What is the product code of K872906?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.