FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VINCO BRAND ACUPUNCTURE NEEDLE
K Number: K024207
·
Decision Apr 14, 2003
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
90
Applicant Total
12
Review Days
115
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Basic Information
- Device Name
- VINCO BRAND ACUPUNCTURE NEEDLE
- K Number
- K024207
- 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
- December 20, 2002
- Decision Date
- April 14, 2003
- 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 |
| K072778 | BRIO ACUPUNCTURE NEEDLES | Nov 19, 2007 | Substantially Equivalent |
| K062448 | LYRA ACUPUNCTURE NEEDLES | Sep 20, 2006 | Substantially Equivalent |
| K052723 | SEVEN STAR NEEDLE | Jan 13, 2006 | Substantially Equivalent |
| K050295 | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES | Mar 25, 2005 | Substantially Equivalent |
| K043277 | C&G ACUPUNCTURE NEEDLE | Feb 8, 2005 | Substantially Equivalent |
| K012583 | ACUGLIDE BRAND ACUPUNCTURE NEEDLES | Dec 11, 2001 | Substantially Equivalent |
| K991507 | KANGNIAN BRAND ACUPUNCTURE NEEDLE | Aug 27, 1999 | Substantially Equivalent |
| K991508 | ACUMASTER BRAND ACUPUNCTURE NEEDLE | Aug 27, 1999 | Substantially Equivalent |
| K961339 | CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES | Jul 3, 1996 | Substantially Equivalent |