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510(k) K921304

DDV LIGATOR by North American Medical, Inc. — Product Code KOA

K921304 is an FDA 510(k) premarket notification submitted by North American Medical, Inc. for the device "DDV LIGATOR". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
March 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances for product code KOA

  • K182664 — FiXcision (December 7, 2018)
  • K950267 — URETHRAL SUTURE GUIDE (January 31, 1995)
  • K932465 — LI VASECTOMY (March 2, 1994)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)

FDA data resources