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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 Jul 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 17 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 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
510(k) Exempt

Other clearances by J. Sklar Mfg. Co., Inc.

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

Other clearances for product code KOA

  • K182664 — FiXcision (Dec 7, 2018)
  • K950267 — URETHRAL SUTURE GUIDE (Jan 31, 1995)
  • K932465 — LI VASECTOMY (Mar 2, 1994)
  • K921546 — VASOVASOSTOMY SET (Jul 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (Oct 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (Sep 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (Sep 14, 1992)
  • K922192 — VAS DILATOR (Aug 7, 1992)
  • K896058 — GRASPING FORCEPS (Dec 28, 1989)

FDA data resources

Source: FDA 510(k) database entry for K801273. Report a data issue: hello@regdatalab.com.