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 |
|---|---|---|---|
| 00810240701144 | G Surgical Marksman System | G SURGICAL LLC | 2026-11-05 |
| 00810240701151 | G Surgical Marksman System | G SURGICAL LLC | 2026-11-05 |
| 07630055307743 | ROSA® Hip CT Instrument Tray - Short | Incipio Devices SA | 2026-11-05 |
| 07630055307750 | ROSA® Hip CT Instrument Tray - Tall | Incipio Devices SA | 2026-11-05 |
| 10889950159429 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2026-11-05 |
| 00810240701137 | G Surgical Marksman System | G SURGICAL LLC | 2026-11-05 |
| 08800424704087 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| B382SD9233161140 | Surgical Direct | Surgical Direct, Inc. | 2026-11-03 |
| 08800424704094 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-11-03 |
| 08800424704070 | GSS™ and AnyPlus® | GS Medical Co., Ltd. | 2026-11-03 |
| 08800322759509 | GSS™ and AnyPlus® | GS Medical Co., Ltd. | 2026-11-03 |
| 05055662976717 | Volition™ Plating System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2026-11-03 |
| 05055662976694 | Volition™ Plating System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2026-11-03 |
| 00889024713505 | G7® TM Acetabular System | Zimmer, Inc. | 2026-11-03 |
| 00842078110102 | AlignX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078110003 | CompressX2 | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078109373 | CarpalFiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078109359 | IO FiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078108253 | APEX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078107935 | XMCP | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078103098 | IO FiX Trio | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078102770 | IO FiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078101896 | Jones Union | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100349 | XMCP | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100332 | IO FiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100240 | HammerFiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100233 | HammerFiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100226 | HammerFiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100202 | HammerFiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |
| 00842078100196 | HammerFiX | EXTREMITY MEDICAL, LLC | 2026-11-02 |