Laceration Tray
FDA 510(k) K955658 · Transidyne General Corp.
510(k) numberK955658
Submission
- Device name
- Laceration Tray
- Applicant
- Transidyne General Corp.
Spartanburg, SC, US - Received
- December 12, 1995
- Decision date
- January 25, 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 |
|---|---|---|
| K961217 | Bodily Fluid Disposal KitFXX · Traditional | 07/25/1996SE |
| K950773 | Prophylaxis PackEGS · Traditional | 03/31/1995SESK |
| K950743 | Oral Procedure PackEGS · Traditional | 03/31/1995SESK |
| K950449 | Surgical BurGFF · Traditional | 03/01/1995SE |
| K950403 | Surgical Saw BladesGFA · Traditional | 02/21/1995SE |
| K924811 | I.V. Start KitLRS · Traditional | 06/17/1993SEKD |
| K924243 | Tracheostomy Care KitJOH · Traditional | 06/16/1993SEKD |
| K922339 | Suture Removal KitMCZ · Traditional | 12/11/1992SESK |
| K922041 | Primary Surgical Dressing TrayFMF · Traditional | 11/06/1992SEKD |
| K897133 | Model 1050 - Umbilical Cord Blood Sampling KitCBT · Traditional | 03/30/1990SE |
Questions and answers
When was Laceration Tray cleared by the FDA?
Laceration Tray (K955658) received a 510(k) decision of Substantially Equivalent on January 25, 1996, 44 days after the submission was received.
What is the product code of K955658?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.