Incare Hot/Ice Absorbent Interface
FDA 510(k) K913035 · Hollister, Inc.
510(k) numberK913035
Submission
- Device name
- Incare Hot/Ice Absorbent Interface
- Applicant
- Hollister, Inc.
Libertyville, IL, US - Received
- July 9, 1991
- Decision date
- September 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | 05/18/2026SE |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional | 10/03/2025SE |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional | 05/03/2024SE |
| K220667 | Sleeved ICEZD · Traditional | 12/08/2022SE |
| K213575 | Female IC (Not Finalized)EZD · Traditional | 09/13/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | 01/27/2022SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | 12/13/2019SE |
| K191633 | Infyna ChicGBM · Special | 07/19/2019SE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special | 12/18/2018SE |
| K180824 | VaPro 2 Intermittent CatheterGBM · Special | 06/22/2018SE |
Questions and answers
When was Incare Hot/Ice Absorbent Interface cleared by the FDA?
Incare Hot/Ice Absorbent Interface (K913035) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 78 days after the submission was received.
What is the product code of K913035?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.