FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DACOMED PENILE PROSTHESIS SIZER
K Number: K870320
·
Decision Mar 17, 1987
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
20
Review Days
48
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
- DACOMED PENILE PROSTHESIS SIZER
- K Number
- K870320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dacomed Corp.
- Date Received
- January 28, 1987
- Decision Date
- March 17, 1987
- Product Code
- JLW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLW), ordered by most recent decision date.
Atellica® IM TSH3-Ultra II (TSH3ULII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Dacomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953640 | DUNA II PENILE PROSTHESIS | Oct 27, 1995 | Substantially Equivalent |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Aug 25, 1994 | Substantially Equivalent |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | May 11, 1992 | Substantially Equivalent |
| K920420 | DURA II PENILE PROSTHESIS | Apr 16, 1992 | Substantially Equivalent |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Oct 11, 1991 | Substantially Equivalent |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | May 4, 1990 | Substantially Equivalent |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Feb 8, 1989 | Substantially Equivalent |
| K880391 | DACOMED CYSTOMETER | Apr 27, 1988 | Substantially Equivalent |
| K871653 | DURAPHASE PENILE PROSTHESIS | Sep 18, 1987 | Substantially Equivalent |
| K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS | Mar 17, 1986 | Substantially Equivalent |