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
GAB Needle, Suturing, Disposable

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GAB), ordered by most recent decision date.

View all

Other Clearances by Anchor Products Co.

K Number Device Name
K091930 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
K061555 ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
K982073 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
K884862 ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
K873124 ANCHOR BIOPSY NEEDLE
K790405 ANCHOR BRAND COUNT-TAINER