Radovan Subcutaneous Tissue Expander
FDA 510(k) K833502 · American Heyer Schulte
510(k) numberK833502
Submission
- Device name
- Radovan Subcutaneous Tissue Expander
- Applicant
- American Heyer Schulte
Mchenry, IL, US - Received
- October 5, 1983
- Decision date
- February 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LCJ
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|---|---|---|---|
| K254126 | Natrelle 133S Tissue ExpandersLCJ · Special | AbbVie | 01/16/2026SE |
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture TabsLCJ · Traditional | Mentor Worldwide, LLC | 04/24/2025SE |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 01/12/2025SE |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 08/02/2024SE |
| K211676 | Motiva Flora SmoothSilk Tissue ExpanderLCJ · Traditional | Motiva USA, LLC | 10/13/2023SE |
| K214124 | AlloX2 Pro Tissue ExpandersLCJ · Traditional | Sientra, Inc. | 06/08/2023SE |
| K221127 | Sientra, inc. PortfinderLCJ · Traditional | Sientra, Inc. | 05/10/2023SE |
| K180826 | Natrelle 133 Plus MICROCELL Tissue ExpanderLCJ · Traditional | Allergan | 12/21/2018SE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special | Mentor Worldwide, LLC | 09/25/2018SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | Allergan | 08/29/2018SE |
More from Allergan
| 510(k) | Device | Decision |
|---|---|---|
| K840172 | Ventral Wall Defect Reduct SiloFTL · Traditional | 06/27/1984SE |
| K834593 | One-Piece ShuntJXG · Traditional | 04/03/1984SE |
| K833698 | Amer. V. Mueller Surg. Staples IlaGDW · Traditional | 01/25/1984SE |
| K833704 | Amer. V. Mueller Surgicalstaples-CartrGDW · Traditional | 12/29/1983SE |
| K832738 | Heyer-Schulte Afterloading CatheterIWJ · Traditional | 09/29/1983SE |
| K823790 | Ventricular Access SystemLKG · Traditional | 04/28/1983SE |
| K822096 | Chemotherapy Infusion CatheterJCY · Traditional | 04/12/1983SE |
| K822032 | Large Volume Closed Wound Suction DrainGCY · Traditional | 08/16/1982SE |
| K820247 | External Ventricular Drainage Sys.JXG · Traditional | 02/18/1982SE |
| K811288 | Spetzler Lumbar-Peritoneal SystemJXG · Traditional | 06/26/1981SE |
Questions and answers
When was Radovan Subcutaneous Tissue Expander cleared by the FDA?
Radovan Subcutaneous Tissue Expander (K833502) received a 510(k) decision of Substantially Equivalent on February 3, 1984, 121 days after the submission was received.
What is the product code of K833502?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.