Product code FSM
- Device name
- Tray, Surgical, Instrument
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | 1997-05-06 |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | 1996-08-09 |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | 1994-11-22 |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | 1991-08-26 |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | 1991-08-20 |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | 1991-05-31 |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | 1991-05-21 |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | 1991-03-06 |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | 1991-02-19 |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | 1990-04-10 |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | 1990-03-15 |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | 1990-02-13 |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | 1989-10-06 |
| K883125 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Brevet, Inc. | 1988-07-28 |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | 1987-06-01 |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | 1987-05-07 |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Medsurg Industries, Inc. | 1987-04-10 |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | North Coast Medi-Tek | 1987-03-05 |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Scanlan Intl., Inc. | 1987-01-12 |
| K863726 | INSTRUMENT STERILIZATION TRAY | Medical Technology Development Corp. | 1986-10-14 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | 1986-07-17 |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Rmp Co. | 1986-06-16 |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | 1986-05-30 |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | D & D Products, Inc. | 1986-05-06 |
| K860160 | OPERATING ROOM TRAY | Medical Design Concepts, Inc. | 1986-02-27 |
| K854746 | SURGICAL INSTRUMENT TRAY | Zbi, Inc. | 1985-12-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00889024699939 | N/A | Zimmer, Inc. | 2026-10-20 |
| 00889024699946 | N/A | Zimmer, Inc. | 2026-10-20 |
| 00889024699953 | Alliance Glenoid, Identity Humeral | Zimmer, Inc. | 2026-10-20 |
| 00810161900930 | EARP RETRACTOR TRAY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900947 | EARP RETRACTOR LID | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900954 | EARP, TRIAL CADDY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900961 | EARP, TRIAL LID | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810111228428 | Instrument Tray | Treace Medical Concepts, Inc. | 2026-10-16 |
| 00810161900909 | EARP IMPLANT TRAY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900916 | EARP INSTRUMENT TRAY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900978 | EARP, DISC SPACER CADDY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900985 | EARP, DISC SPACER LID | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161901746 | EARP INSTRUMENT #2 TRAY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161901753 | EARP INSTRUMENT #2 LID | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161901814 | EARP, PLATFORM CADDY | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00810161900923 | EARP INSTRUMENT AND IMPLANT LID | RETROPSOAS TECHNOLOGIES, LLC | 2026-10-16 |
| 00887868519130 | iASSIST® Knee System | Orthosoft Inc | 2022-11-14 |
| 00887868519161 | iASSIST® Knee System | Orthosoft Inc | 2022-11-14 |
| 00887868519154 | iASSIST® Knee System | Orthosoft Inc | 2022-11-14 |
| 00887868519147 | iASSIST® Knee System | Orthosoft Inc | 2022-11-14 |
| 00888118086037 | SILICONE MAT | KLS-Martin L.P. | 2020-06-19 |
| 00888118125729 | TRAY | KLS-Martin L.P. | 2020-06-19 |
| 00889024516823 | ROSA® KNEE VANGUARD® ID PLATE | Orthosoft Inc | 2019-03-06 |
| 00889024516816 | ROSA® KNEE NEXGEN® ID PLATE | Orthosoft Inc | 2019-03-06 |
| 00889024516809 | ROSA® KNEE PERSONA® ID PLATE | Orthosoft Inc | 2019-03-06 |
| 00889024305496 | iASSIST® Knee System | Orthosoft Inc | 2016-09-07 |
| 00889024305489 | iASSIST | Orthosoft Inc | 2016-09-07 |
| 00889024305472 | iASSIST® Knee System | Orthosoft Inc | 2016-09-07 |
| 00889024304987 | iASSIST® Knee System | Orthosoft Inc | 2016-09-07 |
| 00889024304994 | iASSIST® Knee System | Orthosoft Inc | 2016-09-07 |