Surgitek Intra-Span Intraoperative Tissue Expander
FDA 510(k) K902349 · Surgitek
510(k) numberK902349
Submission
- Device name
- Surgitek Intra-Span Intraoperative Tissue Expander
- Applicant
- Surgitek
Paso Robles, CA, US - Received
- May 25, 1990
- Decision date
- September 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | Wells Johnson Co. | 01/28/1999SE |
| 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 |
| 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 |
More from Cox-Uphuff Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K946296 | Quadra-Coil Ureteral StentFAD · Traditional | 03/06/1995SE |
| K944391 | OM-4 (Tenative) Urodynamic Measruement SystemFEN · Traditional | 02/07/1995SE |
| K943491 | Right Angle Urologic Laser FiberGEX · Traditional | 08/05/1994SE |
| K941952 | Surgitek InfuserFAD · Traditional | 05/24/1994SE |
| K933261 | Grasping ForcepsFGO · Traditional | 01/11/1994SE |
| K933260 | Helical Stone/Flatwire Stone BasketsFFL · Traditional | 01/11/1994SE |
| K930733 | Ureteral StentFAD · Traditional | 07/23/1993SE |
| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
| K926344 | Hydrophilic Coated GuidewireKNY · Traditional | 03/05/1993SE |
| K920451 | Endotek Ultra SystemFAP · Traditional | 09/17/1992SE |
Questions and answers
When was Surgitek Intra-Span Intraoperative Tissue Expander cleared by the FDA?
Surgitek Intra-Span Intraoperative Tissue Expander (K902349) received a 510(k) decision of Substantially Equivalent on September 5, 1990, 103 days after the submission was received.
What is the product code of K902349?
The FDA product code is FZW – Expander, Surgical, Skin Graft, a Class I (low risk) device regulated under 21 CFR 878.4800.