Field Suction Dissector
FDA 510(k) K803292 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK803292
Submission
- Device name
- Field Suction Dissector
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US - Received
- December 30, 1980
- Decision date
- January 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDI – Dissector, 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 GDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896383 | Disposable External ClampsGDI · Traditional | Galenica Enterprises, Inc. | 12/06/1989SE |
| K850288 | Hepatic Parenchymal Suction DissectorGDI · Traditional | Beecher Medical Diagnostic Instrumentation | 03/18/1985SE |
| K831912 | Round-Beehive- Dissectors 3/8GDI · Traditional | Ormed Mfg., Inc. | 10/31/1983SE |
| K822569 | Tympanoplasty & Skin DissectorsGDI · Traditional | Kelleher Corp. | 10/06/1982SE |
| K791870 | Disposable Speciality SpongesGDI · Traditional | Carwild Corp. | 11/05/1979SE |
| K791703 | Tew Bypass Instruments & Dissecting KitGDI · Traditional | Edward Weck, Inc. | 10/04/1979SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K792383 | Kelman DipstickHOE · Traditional | 12/11/1979SE |
| K771197 | Norton EndotrachealBTR · Traditional | 08/16/1977SE |
| K771302 | Pfister-Schwartz Stone RetrieverFGO · Traditional | 08/02/1977SE |
| K770959 | Bougie, Filiform, JacksonKBI · Traditional | 06/14/1977SE |
| K770280 | Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional | 04/15/1977SE |
| K760851 | Converse Altar RetractorKAL · Traditional | 03/10/1977SE |
| K761242 | Teflon Coated Resectoscope SheathFJL · Traditional | 12/16/1976SE |
| K760273 | LithotriteFGK · Traditional | 12/06/1976SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
| K760184 | Element, WorkingFDC · Traditional | 12/02/1976SE |
Questions and answers
When was Field Suction Dissector cleared by the FDA?
Field Suction Dissector (K803292) received a 510(k) decision of Substantially Equivalent on January 29, 1981, 30 days after the submission was received.
What is the product code of K803292?
The FDA product code is GDI – Dissector, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.