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510(k) K831648

ANCHOR BRAND SURGICAL NEEDLES by Anchor Products Co. — Product Code GAB

K831648 is an FDA 510(k) premarket notification submitted by Anchor Products Co. for the device "ANCHOR BRAND SURGICAL NEEDLES". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800. Anchor Products Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Suturing, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Anchor Products Co.

  • K091930 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB (September 23, 2009)
  • K061555 — ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM (August 31, 2006)
  • K982073 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM (September 22, 1998)
  • K884862 — ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (December 27, 1988)
  • K873124 — ANCHOR BIOPSY NEEDLE (September 8, 1987)
  • K790405 — ANCHOR BRAND COUNT-TAINER (March 26, 1979)

Other clearances for product code GAB

  • K012199 — DIGICAP (December 19, 2001)
  • K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (May 11, 1998)
  • K932591 — ENDO-JUDGE (December 22, 1993)
  • K895681 — CONTRAST BACKGROUND MATERIAL (October 24, 1989)
  • K863595 — COATED SUTURE NEEDLE (October 24, 1986)
  • K812444 — RADIATION STERILIZATION FOR NEEDLE CNTR (December 14, 1981)
  • K801976 — SCANLAN STERNUM NEEDLE-SUTURE (September 26, 1980)

FDA data resources