FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COATED SUTURE NEEDLE
K Number: K863595
·
Decision Oct 24, 1986
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
7
Applicant Total
9
Review Days
39
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Basic Information
- Device Name
- COATED SUTURE NEEDLE
- K Number
- K863595
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sharpoint, Inc.
- Date Received
- September 15, 1986
- Decision Date
- October 24, 1986
- Product Code
- GAB
- 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 |
|---|---|---|---|
| GAB | Needle, Suturing, Disposable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Sharpoint, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861947 | SURGICAL KNIFE | Jun 6, 1986 | Substantially Equivalent |
| K840764 | EAR KNIVES | May 21, 1984 | Substantially Equivalent |
| K840855 | CORNEAL SCLERAL LANCE | May 9, 1984 | Substantially Equivalent |
| K840659 | ANTERIOR CAPSULECTOMY CYSTITOME | Mar 16, 1984 | Substantially Equivalent |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Mar 16, 1984 | Substantially Equivalent |
| K830522 | STAINLESS STEEL SUTURE 316L | Mar 31, 1983 | Substantially Equivalent |
| K822112 | OPHTHALMIC KNIFE | Aug 10, 1982 | Substantially Equivalent |
| K821440 | V LANCE | Jun 14, 1982 | Substantially Equivalent |