FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CURITY SURGICAL SCRUB BRUSH SPONGE
K Number: K820086
·
Decision Jan 28, 1982
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
63
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CURITY SURGICAL SCRUB BRUSH SPONGE
- K Number
- K820086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- The Kendal Co.
- Date Received
- January 12, 1982
- Decision Date
- January 28, 1982
- Product Code
- GEC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEC | Brush, Scrub, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEC), ordered by most recent decision date.
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EXPANDACELL INSTRUMENT WIPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIODYNE INSTRUMENT WIPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGI-BRUSH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERILE SCRUBBY SCRUB BRUSH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERI-CLENS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by The Kendal Co.
| K Number | Device Name | ||
|---|---|---|---|
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | Mar 17, 2000 | Substantially Equivalent |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | Sep 28, 1999 | Substantially Equivalent |
| K991758 | MONOJECT INSULIN SYRINGE | Jun 14, 1999 | Substantially Equivalent |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | Apr 23, 1997 | Substantially Equivalent |
| K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | Apr 25, 1995 | Substantially Equivalent |
| K942664 | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM | Jan 17, 1995 | Substantially Equivalent |
| K942774 | POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING | Jul 20, 1994 | Substantially Equivalent for Some Indications |
| K892434 | KENDALL CURITY OXYGEN MASK | Aug 15, 1989 | Substantially Equivalent |
| K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES | Jul 24, 1989 | Substantially Equivalent |
| K892440 | KENDALL CURITY EXTENSION TUBES | Jul 24, 1989 | Substantially Equivalent |