Bircoll Balloon Dissector
FDA 510(k) K984448 · Wells Johnson Co.
510(k) numberK984448
Submission
- Device name
- Bircoll Balloon Dissector
- Applicant
- Wells Johnson Co.
Tucson, AZ, US - Received
- December 14, 1998
- Decision date
- January 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FZW – Expander, Surgical, Skin Graft
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080158 | LB Medical Inflatable Tissue Elevator/Expander SystemFZW · Traditional | Lb Medical LLC | 05/02/2008SE |
| K972109 | Spacemaker Surgicalballoon Dissector/ExpanderFZW · Traditional | General Surgical Innovations | 11/14/1997SE |
| K936186 | Aesculap Skin Graft MesherFZW · Traditional | Aesculap, Inc. | 03/10/1994SE |
| K904265 | Inamed Ruiz-Cohen Intraoperative Tissue ExpanderFZW · Traditional | Inamed Development Co. | 03/06/1991SE |
| K902349 | Surgitek Intra-Span Intraoperative Tissue ExpanderFZW · Traditional | Surgitek | 09/05/1990SE |
| K883303 | Mentor Rapid-Span (TM) Tissue ExpanderFZW · Traditional | Mentor Corp. | 08/26/1988SE |
| K874276 | Cui, Versafil(Tm), Ste(Tm) Tissue ExpanderFZW · Traditional | Cox-Uphuff Intl. | 12/02/1987SE |
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| K991437 | Wells Johnson Infusion System, Model 20-6000-00FRN · Traditional | 08/30/1999SE |
| K971580 | Uas Ultrasonic Aspirator SystemLFL · Traditional | 12/09/1997SE |
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | 12/04/1995SE |
| K945500 | Wells Johnson Fixation SystemJEY · Traditional | 09/21/1995SE |
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | 06/14/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | 03/02/1995SE |
| K945805 | Wells Johnson Weco Monopolar/Frazier Suction ProbeGEI · Traditional | 12/13/1994SE |
| K854068 | External Mechanical Fastener · Traditional | 11/22/1985SE |
| K843188 | Wells Johnson Co. Chaj-Chir-Suction TipJOL · Traditional | 09/20/1984SE |
| K832521 | Plastic Suction TipsGEA · Traditional | 10/20/1983SE |
Questions and answers
When was Bircoll Balloon Dissector cleared by the FDA?
Bircoll Balloon Dissector (K984448) received a 510(k) decision of Substantially Equivalent on January 28, 1999, 45 days after the submission was received.
What is the product code of K984448?
The FDA product code is FZW – Expander, Surgical, Skin Graft, a Class I (low risk) device regulated under 21 CFR 878.4800.