RNS, Sterile Disposable Percutaneous Cholangiographic Tray
FDA 510(k) K955686 · Contour Fabricators of Florida, Inc.
510(k) numberK955686
Submission
- Device name
- RNS, Sterile Disposable Percutaneous Cholangiographic Tray
- Applicant
- Contour Fabricators of Florida, Inc.
Palm Harobor, FL, US - Received
- December 14, 1995
- Decision date
- February 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRG – Wrap, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code FRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
More from Turbett Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K955685 | RNS Sterile, Disposable CT Biopsy TrayDXT · Traditional | 10/04/1996SE |
| K962040 | RNS Arthrogram TrayFMI · Traditional | 06/25/1996SE |
| K955687 | RNS Sterile, Disposable Radiographic Contrast TrayJAA · Traditional | 06/03/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | 05/15/1996SE |
| K955684 | RNS Sterile, Disposable Angiographic TrayDXT · Traditional | 05/02/1996SESK |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | 03/12/1996SE |
| K955688 | RNS Sterile, Disposable Standard Biopsy TrayFRG · Traditional | 02/21/1996SE |
| K955678 | RNS Sterile Disposable Puncture TrayFRG · Traditional | 02/21/1996SE |
| K955683 | RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional | 02/01/1996SE |
| K952396 | Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride SolutionBSY · Traditional | 08/15/1995SE |
Questions and answers
When was RNS, Sterile Disposable Percutaneous Cholangiographic Tray cleared by the FDA?
RNS, Sterile Disposable Percutaneous Cholangiographic Tray (K955686) received a 510(k) decision of Substantially Equivalent on February 21, 1996, 69 days after the submission was received.
What is the product code of K955686?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.