Minor Laceration Tray W/ Instrument, Sterile, Disp
FDA 510(k) K920517 · Trinity Laboratories, Inc.
510(k) numberK920517
Submission
- Device name
- Minor Laceration Tray W/ Instrument, Sterile, Disp
- Applicant
- Trinity Laboratories, Inc.
Salisbury, MD, US - Received
- February 4, 1992
- Decision date
- May 11, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
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| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
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| K965201 | O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional | 02/14/1997SEKD |
| K964921 | Basic Biopsy Tray. Disposable, SterileLRO · Traditional | 01/22/1997SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | 11/16/1995SE |
| K952058 | Sterile V.A.D. (Vascular Access Devices) Access Kit, DisposableFOZ · Traditional | 09/21/1995SE |
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Questions and answers
When was Minor Laceration Tray W/ Instrument, Sterile, Disp cleared by the FDA?
Minor Laceration Tray W/ Instrument, Sterile, Disp (K920517) received a 510(k) decision of Unknown on May 11, 1992, 97 days after the submission was received.
What is the product code of K920517?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.