FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TEX-AID BLUE
K Number: K955856
·
Decision Feb 16, 1996
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
11
Review Days
52
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
- TEX-AID BLUE
- K Number
- K955856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laborie Medical Technologies, Ltd.
- Date Received
- December 26, 1995
- Decision Date
- February 16, 1996
- Product Code
- LKY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKY), ordered by most recent decision date.
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VACURECT VACUUM CONSTRICTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANMA VACUUM PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO NANMA VACUUM PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Laborie Medical Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | Jul 21, 2009 | Substantially Equivalent |
| K962009 | UROSTYM | May 20, 1997 | Substantially Equivalent |
| K955810 | U-TEX | Jan 24, 1996 | Substantially Equivalent |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Jul 6, 1995 | Substantially Equivalent |
| K942563 | ELITE BIOFEEDBACK | Jun 6, 1995 | Substantially Equivalent |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Jul 12, 1994 | Substantially Equivalent |
| K934369 | DRI SLEEPER | Nov 24, 1993 | Substantially Equivalent |
| K931574 | ADVANCE MODEL UDS-ADV | Aug 5, 1993 | Substantially Equivalent |
| K930005 | DRITRAINER | Mar 3, 1993 | Substantially Equivalent |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Oct 20, 1992 | Substantially Equivalent |