LRO — General Surgery Tray Class II
Classification Details
- Product Code
- LRO
- Device Class
- Class II
- Regulation Number
- 878.4370
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213481 | medline industries | Medline General Surgery Tray | May 24, 2022 |
| K212258 | medline industries | Medline Cardiovascular Procedure Kit | December 3, 2021 |
| K041080 | d.i.r.r.a | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | November 30, 2004 |
| K030721 | ballard medical products | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | March 31, 2003 |
| K023276 | amsino international | AMSINO TRACHEOSTOMY CARE TRAY | December 9, 2002 |
| K980137 | worldwide medical technologies | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | January 30, 1998 |
| K971061 | opportunity | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | June 11, 1997 |
| K971062 | opportunity | OPPORTUNITY INC. GENERAL PURPOSE TRAY | June 9, 1997 |
| K932221 | associated medical products | NEUROLOGICAL OR CRANI TRAYS (PACKS) | March 19, 1997 |
| K970286 | medline industries | PRESBYTERIAN LINEN SERVICES SURGICAL PACKS | March 10, 1997 |
| K965201 | trinity laboratories | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | February 14, 1997 |
| K970187 | gi supply | RUNYON LARGE VOLUME PARACENTESIS KIT | February 14, 1997 |
| K964921 | trinity laboratories | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | January 22, 1997 |
| K963721 | grand medical products | SKIN SCRUB TRAY | November 27, 1996 |
| K963715 | grand medical products | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | November 27, 1996 |
| K964011 | customed | SUCTION CATHETER TRAY PRODUCT NO. 900277 | November 25, 1996 |
| K963443 | continental medical laboratories | PROD. NO. 02-031 - LACERATION TRAY | October 17, 1996 |
| K962826 | medline industries | MEDLINE RADIOLOGY-DIAGNOSTIC KITS | September 16, 1996 |
| K961863 | tri-med | PARACENTESIS TRAYS | May 28, 1996 |
| K953083 | hospital laundry services | HOSPITAL LAUNDRY SERVICES SURGICAL PACKS | May 14, 1996 |