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510(k) K801273

MAGILL CATHETER INTRO. FORCEPS by J. Sklar Mfg. Co., Inc. — Product Code KOA

K801273 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "MAGILL CATHETER INTRO. FORCEPS". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
May 29, 1980
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 J. Sklar Mfg. Co., Inc.

  • K843693 — JACOBS HIGH VACUUM SUCTION UNIT 05-2570 (October 31, 1984)
  • K842112 — TISCHLER CERVICAL BIOPSY PUNCH FORCEPS (July 3, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K802458 — KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 (January 12, 1981)
  • K802457 — KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 (January 12, 1981)
  • K800441 — RUDD-CLINIC HEMORRHOIDAL FORCEPS (April 8, 1980)
  • K790577 — HEMORRHOIDAL LIGATOR (April 23, 1979)
  • K772229 — MINICLAMPS, STABILIZ., FALLOPIAN TUBE (January 3, 1978)
  • K772230 — CANNULA, PERFUSION, FALLOPIAN TUBE (January 3, 1978)

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