Product code GEC
- Device name
- Brush, Scrub, Operating-Room
- 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 |
|---|---|---|---|
| K971473 | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK | M-Pact Worldwide Management Corp. | 1997-07-07 |
| K960621 | EXPANDACELL INSTRUMENT WIPE | Shippert Medical Technologies Corp. | 1996-04-01 |
| K900691 | BIODYNE INSTRUMENT WIPES | Bio-Dyne, Inc. | 1990-03-08 |
| K896085 | SURGI-BRUSH | Sparta Surgical Corp. | 1989-11-08 |
| K875033 | STERILE SCRUBBY SCRUB BRUSH | Medsurg Industries, Inc. | 1988-02-19 |
| K875129 | STERI-CLENS | Absorbent Cotton Co., Inc. | 1988-02-18 |
| K872823 | DELTA SCRUB | Pacific Biosystems, Inc. | 1988-01-07 |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Surgikos, Inc. | 1987-12-30 |
| K874741 | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | Absorbent Cotton Co., Inc. | 1987-12-10 |
| K870258 | BIOSCRUB SURGICAL SCRUB BRUSH | K. W. Griffen Co. | 1987-02-24 |
| K854232 | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES | American Pharmaseal Div. Ahsc | 1985-12-10 |
| K844411 | SCRUB MATE DRY STERILE SCRUB BRUSH | American Sterilizer Co. | 1984-12-17 |
| K843636 | FOAM CARE ONE STEP PREP | Ballard Medical Products | 1984-11-16 |
| K831488 | DAVRON PROF. SCRUB BRUSH-DRY/STERILE | Minnetonka, Inc. | 1983-06-08 |
| K831226 | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 | Ballard Medical Products | 1983-05-16 |
| K830394 | PROVIDONE-IODINE PREP-PADS & TOWELETTES | H & P Industries, Inc. | 1983-04-06 |
| K830393 | PROVIDONE-IODINE SWABSTICKS | H & P Industries, Inc. | 1983-04-06 |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | The Buckeye Cellulose Corp. | 1982-11-22 |
| K823061 | BRUSH, SCRUB, OPERATING ROOM | Seamless Hospital Products Co. | 1982-11-05 |
| K822865 | SURGI-SCRUB V | Acme United Corp. | 1982-10-18 |
| K821497 | DISPOSABLE SURGICAL SCRUB BRUSHES | Medical Systems Research | 1982-07-14 |
| K820086 | CURITY SURGICAL SCRUB BRUSH SPONGE | The Kendal Co. | 1982-01-28 |
| K810655 | DISPOSABLE SCRUB BRUSH | Dexide, Inc. | 1981-05-05 |
| K810337 | PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 | Nice-Pak Products, Inc. | 1981-02-26 |
| K803116 | HEAVY DRAINAGE PACK | American Medical Disposable, Inc. | 1981-01-28 |
| K800058 | ANAGO ELECTRO SURGICAL TIP CLEANER | Anago, Inc. | 1980-01-28 |
| K792272 | DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO | Dexide, Inc. | 1979-12-27 |
| K792273 | DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P | Dexide, Inc. | 1979-12-10 |
| K792242 | SURGI-PREP PAINT STICK #1 WET PACK | Gard Research Corp. | 1979-12-10 |
| K791952 | DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH | Dexide, Inc. | 1979-10-17 |
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|---|---|---|---|
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| M453882161 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-12 |
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| M453881231 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-12 |
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| M453850031 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-12 |
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| M453885461 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885451 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885441 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885431 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M45388542S1 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885421 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885411 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M45388540S1 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885401 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |
| M453885391 | 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments Inc | 2023-06-09 |