FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANCHOR BRAND SURGICAL NEEDLES
K Number: K831648
·
Decision Aug 16, 1983
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
7
Applicant Total
7
Review Days
85
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
- ANCHOR BRAND SURGICAL NEEDLES
- K Number
- K831648
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Anchor Products Co.
- Date Received
- May 23, 1983
- Decision Date
- August 16, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAB), ordered by most recent decision date.
DIGICAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDO-JUDGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONTRAST BACKGROUND MATERIAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COATED SUTURE NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RADIATION STERILIZATION FOR NEEDLE CNTR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Anchor Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K091930 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB | Sep 23, 2009 | Substantially Equivalent |
| K061555 | ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM | Aug 31, 2006 | Substantially Equivalent |
| K982073 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM | Sep 22, 1998 | Substantially Equivalent |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Dec 27, 1988 | Substantially Equivalent |
| K873124 | ANCHOR BIOPSY NEEDLE | Sep 8, 1987 | Substantially Equivalent |
| K790405 | ANCHOR BRAND COUNT-TAINER | Mar 26, 1979 | Substantially Equivalent |