FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
K Number: K050295
·
Decision Mar 25, 2005
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
90
Applicant Total
12
Review Days
46
Basic Information
- Device Name
- PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
- K Number
- K050295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HELIO MEDICAL SUPPLIES, INC.
- Date Received
- February 7, 2005
- Decision Date
- March 25, 2005
- Product Code
- MQX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | FDA class 2 | General Hospital |
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Other Clearances by HELIO MEDICAL SUPPLIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K080221 | EA STIMULATOR | Sep 9, 2008 | Substantially Equivalent |
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| K062448 | LYRA ACUPUNCTURE NEEDLES | Sep 20, 2006 | Substantially Equivalent |
| K052723 | SEVEN STAR NEEDLE | Jan 13, 2006 | Substantially Equivalent |
| K043277 | C&G ACUPUNCTURE NEEDLE | Feb 8, 2005 | Substantially Equivalent |
| K024207 | VINCO BRAND ACUPUNCTURE NEEDLE | Apr 14, 2003 | Substantially Equivalent |
| K012583 | ACUGLIDE BRAND ACUPUNCTURE NEEDLES | Dec 11, 2001 | Substantially Equivalent |
| K991508 | ACUMASTER BRAND ACUPUNCTURE NEEDLE | Aug 27, 1999 | Substantially Equivalent |
| K991507 | KANGNIAN BRAND ACUPUNCTURE NEEDLE | Aug 27, 1999 | Substantially Equivalent |
| K961339 | CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES | Jul 3, 1996 | Substantially Equivalent |