Home / 510(k) Clearances / K932591

510(k) K932591

ENDO-JUDGE by Synergistic Medical Technologies, Inc. — Product Code GAB

K932591 is an FDA 510(k) premarket notification submitted by Synergistic Medical Technologies, Inc. for the device "ENDO-JUDGE". The FDA issued a decision of Substantially Equivalent on December 22, 1993. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1993
Date Received
May 28, 1993
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 for product code GAB

  • K012199 — DIGICAP (December 19, 2001)
  • K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (May 11, 1998)
  • 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