FSM — Tray, Surgical, Instrument Class I
FDA product code FSM covers "Tray, Surgical, Instrument", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FSM
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971217 | general hospital supply | INSTRUMENT TRAY LINER | May 6, 1997 |
| K962328 | medcare medical group | SINGLE USE INSTRUMENT TRAY | August 9, 1996 |
| K944025 | riley medical | SURGICAL INSTRUMENT TRAY | November 22, 1994 |
| K912106 | medical device inspection co | ARTHROSCOPY TRAY | August 29, 1991 |
| K912053 | medical device inspection co | OPEN HEART TRAY | August 26, 1991 |
| K912052 | medical device inspection co | HEART CATH TRAY | August 20, 1991 |
| K912104 | medical device inspection co | MAJOR BASIN TRAY | August 9, 1991 |
| K910570 | solan scissors sales | SPLINTER TWEEZERS | May 31, 1991 |
| K911601 | ideal medical | REDDICK TROCAR AND CANNULA | May 21, 1991 |
| K910328 | key surgical | KEY COMFORT GRIPS | March 6, 1991 |
| K905682 | richard-allan medical | RICHARD-ALLAN CLAMP COVERS | February 19, 1991 |
| K900376 | pmt | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | April 10, 1990 |
| K894610 | l h m ent | CUSTOM TRAYS, KITS | March 15, 1990 |
| K900479 | busse hospital disposables | STERILE LACERATION TRAY CAT. #749 | February 13, 1990 |
| K895527 | quantitative technologies | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | October 6, 1989 |
| K883193 | terray manufacturing | CASF STERILIZATION TRAY | August 10, 1988 |
| K883125 | terray manufacturing | CASF STERILIZATION TRAY | August 10, 1988 |
| K882617 | brevet | BREVET CASSETTE STERILIZATION MODULE | July 28, 1988 |
| K871924 | arthropedics | STERILIZATION TRAY, TMJ INSTRUMENT SET | June 1, 1987 |
| K871478 | procedure pak | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | May 7, 1987 |