DELTA SCRUB
FDA 510(k) clearance K872823 · decided 1988-01-07
Clearance details
- K-number
- K872823
- Device name
- DELTA SCRUB
- Applicant
- Pacific Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-16
- Decision date
- 1988-01-07
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GEC
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (K971473) | M-Pact Worldwide Management Corp. | 1997-07-07 |
| EXPANDACELL INSTRUMENT WIPE (K960621) | Shippert Medical Technologies Corp. | 1996-04-01 |
| BIODYNE INSTRUMENT WIPES (K900691) | Bio-Dyne, Inc. | 1990-03-08 |
| SURGI-BRUSH (K896085) | Sparta Surgical Corp. | 1989-11-08 |
| STERILE SCRUBBY SCRUB BRUSH (K875033) | Medsurg Industries, Inc. | 1988-02-19 |
| STERI-CLENS (K875129) | Absorbent Cotton Co., Inc. | 1988-02-18 |
| STERILE SURGICAL SCRUB BRUSH (K874653) | Surgikos, Inc. | 1987-12-30 |
| STERI-CLENS(TM) SURGICAL SCRUB SPONGE (K874741) | Absorbent Cotton Co., Inc. | 1987-12-10 |
| BIOSCRUB SURGICAL SCRUB BRUSH (K870258) | K. W. Griffen Co. | 1987-02-24 |
| PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (K854232) | American Pharmaseal Div. Ahsc | 1985-12-10 |
| SCRUB MATE DRY STERILE SCRUB BRUSH (K844411) | American Sterilizer Co. | 1984-12-17 |
| FOAM CARE ONE STEP PREP (K843636) | Ballard Medical Products | 1984-11-16 |
Recalls involving this device
No recalls on record reference this clearance.