Thornton Anterior Chamber Irrigator
FDA 510(k) K771732 · Concept, Inc.
510(k) numberK771732
Submission
- Device name
- Thornton Anterior Chamber Irrigator
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- September 15, 1977
- Decision date
- September 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBQ – Catheter, Continuous Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941356 | Microflow Irrigation SystemGBQ · Traditional | Jedmed Instrument Co. | 05/19/1994SE |
| K921464 | CAT.#40100, 40102, 40104 & 40106 Yankauer Suct IntGBQ · Traditional | Trinity Laboratories, Inc. | 05/05/1992SE |
| K882647 | Gesco Catheterization TrayGBQ · Traditional | Gesco Intl., Inc. | 09/09/1988SESD |
| K874596 | Perforated Soaking TubeGBQ · Traditional | Specialty Medical Products Co. | 12/02/1987SE |
| K873097 | Procedual Changes/Assembly Process for Plus PaksGBQ · Traditional | Ipax, Inc. | 09/04/1987SE |
| K872787 | Modified CurlcathGBQ · Traditional | Quinton, Inc. | 08/04/1987SE |
| K791400 | Gastric Lavage Kit-DisposableGBQ · Traditional | Acumed Instruments Corp. | 08/16/1979SE |
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| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Thornton Anterior Chamber Irrigator cleared by the FDA?
Thornton Anterior Chamber Irrigator (K771732) received a 510(k) decision of Substantially Equivalent on September 28, 1977, 13 days after the submission was received.
What is the product code of K771732?
The FDA product code is GBQ – Catheter, Continuous Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.