Surgical Tray (Sterile)
FDA 510(k) K925022 · Customed, Inc.
510(k) numberK925022
Submission
- Device name
- Surgical Tray (Sterile)
- Applicant
- Customed, Inc.
Fajardo, PR, US - Received
- September 24, 1992
- Decision date
- April 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRD – Applicator, Ent Drug
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5220
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984345 | AromapatchLRD · Traditional | Envis, Inc. | 03/19/1999SE |
| K932522 | Amsco Sterile Recoveries Surgical PacksLRD · Traditional | Amsco Sterile Recoveries, Inc. | 09/09/1994SE |
| K942789 | MistassistLRD · Traditional | The Merlin Corp. | 08/12/1994SE |
| K940133 | The Expandacell Ear PackLRD · Traditional | Denver Splint Co. | 05/23/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | Hospitak, Inc. | 05/15/1992SE |
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| K974647 | Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633KKX · Traditional | 01/05/1998SE |
| K971920 | Gown Poly Reinforced Large(Product NO.900-522)/(REORDER No. 0522)FYA · Traditional | 12/04/1997SE |
| K964011 | Suction Catheter Tray Product No. 900277LRO · Traditional | 11/25/1996SESK |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | 10/04/1996SE |
| K962596 | Customed Blood Extraction KitGJE · Traditional | 09/27/1996SE |
| K961442 | Universal Drainage TrayFCM · Traditional | 05/09/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | 10/02/1995SE |
| K950295 | Wound Closure/Laceration TrayLRO · Traditional | 04/18/1995SE |
| K942177 | Foley Catheterization TrayFCM · Traditional | 09/08/1994SE |
Questions and answers
When was Surgical Tray (Sterile) cleared by the FDA?
Surgical Tray (Sterile) (K925022) received a 510(k) decision of Substantially Equivalent on April 26, 1993, 214 days after the submission was received.
What is the product code of K925022?
The FDA product code is LRD – Applicator, Ent Drug, a Class I (low risk) device regulated under 21 CFR 874.5220.