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 |
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|---|---|---|---|
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| 00889795135285 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2026-09-24 |
| 00889795135292 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2026-09-24 |
| 00889795135308 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2026-09-24 |
| 00889795135315 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2026-09-24 |
| 00889795135322 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2026-09-24 |
| 00889795135339 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2026-09-24 |
| 10889950159221 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2026-09-24 |
| B7685720100 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-04-17 |
| B7685451910 | Buxton Biomedical | BUXTON BIOMEDICAL, INC. | 2023-12-08 |
| B7682486110 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-09-15 |
| B7682485110 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-14 |
| B7685710230 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-02 |
| B7685734110 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-02 |
| B7685735110 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-02 |
| B7685744110 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-02 |
| B7682459050 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-01-10 |
| B7682459070 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-01-10 |
| 07613327482850 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327467802 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327466317 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327466300 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327466294 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327466287 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327466270 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327460971 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 07613327460803 | Navigation Enabled | Stryker Corporation | 2019-10-16 |
| 00613994282439 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-01 |
| 00613994365231 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-11-27 |