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510(k) K801976

SCANLAN STERNUM NEEDLE-SUTURE by Scanlan Intl., Inc. — Product Code GAB

K801976 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN STERNUM NEEDLE-SUTURE". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 19, 1980
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 Scanlan Intl., Inc.

  • K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (April 26, 1996)
  • K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER (December 5, 1994)
  • K911184 — SCANLAN/TAHERI VALVULOTOME (February 18, 1992)
  • K864920 — SCANLAN (TM) INSTRUMENT TRAY (January 12, 1987)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K851825 — SCANLAN TUNNELER, SHEATH & TIP (July 12, 1985)
  • K841521 — SCANLAN ENDARSECTOR (August 3, 1984)
  • K841513 — SCANLAN ATRAUM INSTRUMENT JAW COVER (July 6, 1984)
  • K841085 — SCANLAN COLORMARK SKIN MARKER (June 11, 1984)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)

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)
  • K831648 — ANCHOR BRAND SURGICAL NEEDLES (August 16, 1983)
  • K812444 — RADIATION STERILIZATION FOR NEEDLE CNTR (December 14, 1981)

FDA data resources