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510(k) K834171

OP-CON SURG. INSTRUMENT #3 by Imm Enterprises , Ltd. — Product Code KOA

K834171 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "OP-CON SURG. INSTRUMENT #3". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
November 21, 1983
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 Imm Enterprises , Ltd.

  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (April 23, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)
  • K840310 — CATEGORY 6 OPTHALMIC DEVICES (March 16, 1984)

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)
  • 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)

FDA data resources