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 |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 |
| K883125 | 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 |
|---|---|---|---|
| 00196449035489 | Anatomic Access LLIF | Tyber Medical, LLC | 2026-06-09 |
| 00196449035496 | Anatomic Access LLIF | Tyber Medical, LLC | 2026-06-09 |
| 00196449035502 | Anatomic Access LLIF | Tyber Medical, LLC | 2026-06-09 |
| 00196449035519 | Anatomic Access LLIF | Tyber Medical, LLC | 2026-06-09 |
| 00196449035526 | Anatomic Access LLIF | Tyber Medical, LLC | 2026-06-09 |
| 00889024701670 | Identity® Shoulder System | Zimmer, Inc. | 2026-06-09 |
| 04251047924804 | Sterilizing Case | A1 Medical GmbH | 2026-06-09 |
| 04251047926389 | Sterilization Tray with Lid | A1 Medical GmbH | 2026-06-09 |
| 04251047930386 | Double-level Sterilization Tray | A1 Medical GmbH | 2026-06-09 |
| 00196449010134 | Anatomic Access LLIF | Tyber Medical, LLC | 2026-06-09 |
| 00810055257898 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257942 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257935 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257928 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257911 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257904 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257881 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00810055257874 | Surgical Design | Surgical Design, Inc. | 2026-06-06 |
| 00857915007750 | Endo ECTR Tray | A.M. SURGICAL, INC. | 2026-06-04 |
| 10705037042999 | STERRAD™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2026-06-03 |
| 07613327605716 | PANGEA | Stryker GmbH | 2026-06-02 |
| 07613327623260 | Mako | MAKO SURGICAL CORP. | 2026-05-29 |
| 10886982312266 | NA | Synthes GmbH | 2022-06-17 |
| 10886982312259 | NA | Synthes GmbH | 2022-04-12 |
| 50885380102590 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-25 |
| 00821925022003 | GYRUS ACMI | Gyrus ACMI, LLC | 2018-09-13 |
| 00821925013124 | Gyrus ACMI | Gyrus ACMI, LLC | 2018-09-10 |
| 00821925015685 | GYRUS ACMI, INC | Gyrus ACMI, LLC | 2018-09-10 |
| 10886982255297 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10886982184108 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |