Rolled Neck W/Plug
FDA 510(k) K841411 · Warne Surgical Products, Ltd.
510(k) numberK841411
Submission
- Device name
- Rolled Neck W/Plug
- Applicant
- Warne Surgical Products, Ltd.
Mchenry, IL, US - Received
- April 5, 1984
- Decision date
- April 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTC – Bag, Reservoir
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5320
- Specialty
- Anesthesiology
Other 510(k)s with product code BTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181424 | PeDIABTC · Traditional | Pedia, LLC | 09/25/2018SE |
| K940220 | Rebreather BagsBTC · Traditional | Zefon Medical Products | 05/27/1994SE |
| K932584 | Breathing BagsBTC · Traditional | Merit Medical Systems, Inc. | 07/16/1993SE |
| K932581 | Breathing BagsBTC · Traditional | Med-Plastics Intl., Inc. | 07/16/1993SE |
| K932496 | Precision Med Products, Ltd. Breathing BagsBTC · Traditional | Precision Med Products, Ltd. | 07/16/1993SE |
| K932191 | Breathing BagsBTC · Traditional | Life Shield Healthcare Products, Inc. | 07/02/1993SE |
| K894906 | Anesthesia Breathing Bags Sizes 1/2, 1,2,3 LiterBTC · Traditional | Med-Tek Corp. | 09/18/1989SE |
| K880680 | King Systems, Breathing BagBTC · Traditional | King Systems Corp. | 03/03/1988SE |
| K864822 | Varidyne 550, Models 12E,12M,24E & 24M Suction SysBTC · Traditional | Surgidyne, Inc. | 01/15/1987SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
More from Warne Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K850696 | WSP Code 4300 Diomaster DiagnosticFAP · Traditional | 05/17/1985SE |
| K850694 | WSP Code 4310 StresscathFAP · Traditional | 05/17/1985SE |
| K850695 | WSP Code 4301 Diomaster TherapeuticFAP · Traditional | 05/16/1985SE |
| K850693 | WSP Code 4315 PadtestFAP · Traditional | 05/10/1985SE |
| K841511 | Haematuria CathetersKOD · Traditional | 07/12/1984SE |
| K840687 | Kidney Transplant CatheterKDN · Traditional | 06/07/1984SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | 04/18/1984SE |
| K841410 | Bush Neck W/TapDRM · Traditional | 04/18/1984SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | 04/18/1984SE |
| K840704 | Secure W/35MM Diam, Sheath/AdhesiveKNX · Traditional | 03/22/1984SE |
Questions and answers
When was Rolled Neck W/Plug cleared by the FDA?
Rolled Neck W/Plug (K841411) received a 510(k) decision of Substantially Equivalent on April 18, 1984, 13 days after the submission was received.
What is the product code of K841411?
The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.