Byron Word Bartholian Gland Catheter
FDA 510(k) K861877 · Byron Medical
510(k) numberK861877
Submission
- Device name
- Byron Word Bartholian Gland Catheter
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- May 15, 1986
- Decision date
- May 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBA – Catheter, Balloon Type
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802025 | Balloon Retention Chest CatheterGBA · Traditional | Loseff Medical Designers, Ltd. | 09/26/1980SE |
| K790444 | Elecath Multi-Purpose Arterial SurgerGBA · Traditional | Electro-Catheter Corp. | 06/11/1979SE |
| K781772 | Catheter, Transluminal BalloonGBA · Traditional | Medi-Tech, Inc. | 03/06/1979SE |
| K781665 | Tube, Leatherman/ImbruceGBA · Traditional | National Catheter Co. Div. Mallinckrodt | 12/15/1978SE |
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| K980392 | Psi-Tec AspiratorBTA · Traditional | 03/05/1998SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | 02/10/1998SE |
| K973133 | Big Bag 3000 Pressure InfusorFRN · Traditional | 09/12/1997ST |
| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
| K934233 | Zara Zone IV Malar Implant ModificationLZK · Traditional | 02/03/1994SE |
Questions and answers
When was Byron Word Bartholian Gland Catheter cleared by the FDA?
Byron Word Bartholian Gland Catheter (K861877) received a 510(k) decision of Substantially Equivalent on May 30, 1986, 15 days after the submission was received.
What is the product code of K861877?
The FDA product code is GBA – Catheter, Balloon Type, a Class I (low risk) device regulated under 21 CFR 878.4200.