Biopsy Tray
FDA 510(k) K941645 · Cush Medical Products
510(k) numberK941645
Submission
- Device name
- Biopsy Tray
- Applicant
- Cush Medical Products
Piney Flats, TN, US - Received
- April 4, 1994
- Decision date
- July 14, 1994
- Decision
- Unknown (SEKD)
- 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 |
|---|---|---|
| K943424 | Cush Island DressingMGP · Traditional | 10/03/1994SN |
| K940518 | C-Section TrayMLS · Traditional | 08/18/1994SEKD |
| K941349 | Dental TrayEIA · Traditional | 07/26/1994SN |
| K940239 | Eye TrayLRP · Traditional | 06/28/1994SEKD |
| K935684 | IV Start KitLRS · Traditional | 06/10/1994SEKD |
| K941455 | Sterile Gauze Product LineEFQ · Traditional | 05/20/1994SESK |
| K941522 | Sterile X-Ray Detectable Gauze SpongesGDY · Traditional | 05/12/1994SE |
| K941344 | Lap Sponge Product LineGDY · Traditional | 05/12/1994SE |
| K935697 | Circumcision TrayHFX · Traditional | 05/02/1994SEKD |
| K936120 | Labor and Delivery TrayMLS · Traditional | 03/30/1994SEKD |
Questions and answers
When was Biopsy Tray cleared by the FDA?
Biopsy Tray (K941645) received a 510(k) decision of Unknown on July 14, 1994, 101 days after the submission was received.
What is the product code of K941645?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.