Submission Details
| 510(k) Number | K030365 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2003 |
| Decision Date | April 29, 2003 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
DEROYAL DRAPES, STERILE, NON-STERILE
Apr 2003
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K030365 is an FDA 510(k) clearance for the DEROYAL DRAPES, STERILE, NON-STERILE, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on April 29, 2003, 84 days after receiving the submission on February 4, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.
Device Classification
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
Manufacturer
Similar Devices — KKX Drape, Surgical
All 449
K230645 · Avery Dennison Medical , Ltd.
· Oct 2023
K222578 · 3M Company
· May 2023
K202208 · Avery Dennison Belgie Bvba
· Jul 2021
K200238 · Controlrad, Inc.
· Apr 2020
K163556 · Covalontechnologies, Inc.
· Sep 2017
K133080 · Foshan Nanhai Plus Medical Co, Ltd.
· Jun 2015
More from Deroyal Industries, Inc.
View all
K250586
· OMP · Nov 2025
K230233
· OMP · Apr 2024
K200631
· FLL · Dec 2020
K200757
· EYC · Oct 2020
K193027
· BZT · Apr 2020