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510(k) K980988

AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) by Axya Medical, Inc. — Product Code GAB

K980988 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)". The FDA issued a decision of Substantially Equivalent on May 11, 1998. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1998
Date Received
March 17, 1998
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 Axya Medical, Inc.

  • K070773 — AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR (October 11, 2007)
  • K070253 — AXYA SUTURE WELDING SYSTEM AND KIT (July 11, 2007)
  • K063194 — TUFFLEX POLYESTER SUTURE (December 4, 2006)
  • K060165 — AXYAFLEX POLYESTER SUTURE (September 1, 2006)
  • K060970 — AXYALOOP NONABSORBABLE BONE ANCHOR (July 5, 2006)
  • K052491 — AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR (October 7, 2005)
  • K051983 — MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (August 5, 2005)
  • K051250 — AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (June 9, 2005)
  • K041698 — AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (October 5, 2004)
  • K022207 — AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM (October 4, 2002)

Other clearances for product code GAB

  • K012199 — DIGICAP (December 19, 2001)
  • 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)
  • K801976 — SCANLAN STERNUM NEEDLE-SUTURE (September 26, 1980)

FDA data resources