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510(k) K932465

LI VASECTOMY by Femcare , Ltd. — Product Code KOA

K932465 is an FDA 510(k) premarket notification submitted by Femcare , Ltd. for the device "LI VASECTOMY". The FDA issued a decision of Substantially Equivalent on March 2, 1994. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Femcare , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1994
Date Received
May 21, 1993
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 by Femcare , Ltd.

  • K884061 — ADD-A-CATH (October 25, 1988)

Other clearances for product code KOA

  • K182664 — FiXcision (December 7, 2018)
  • K950267 — URETHRAL SUTURE GUIDE (January 31, 1995)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • 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