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510(k) K932456

JARIT SURGICAL INSTRUMENTS by J. Jamner Surgical Instruments, Inc. — Product Code KNF

K932456 is an FDA 510(k) premarket notification submitted by J. Jamner Surgical Instruments, Inc. for the device "JARIT SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. J. Jamner Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1994
Date Received
May 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by J. Jamner Surgical Instruments, Inc.

  • K082349 — JARIT HULKA UTERINE TENACULUM FORCEPS (November 21, 2008)
  • K944670 — JARIT RECOMMENDED SINUS INSTRUMENTS (February 2, 1995)
  • K944870 — JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 (November 2, 1994)
  • K941565 — JARIT RECOMMENDED SINUS INSTRUMENTS (May 16, 1994)
  • K933728 — JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, (February 23, 1994)
  • K931928 — JARIT SURGICAL INSTRUMENTS (November 10, 1993)
  • K931959 — JARIT SURGICAL INSTRUMENTS (October 5, 1993)
  • K931878 — JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 (August 19, 1993)
  • K771625 — LEININGEO AORTIC PUNCH #310-395 & 397 (September 12, 1977)
  • K771624 — COPE LUNG FORCEPS #305-218 (September 6, 1977)

Other clearances for product code KNF

  • K250705 — Sonata Transcervical Fibroid Ablation System 2.2 (April 2, 2025)
  • K240503 — Sonata Transcervical Fibroid Ablation System 2.2 (July 17, 2024)
  • K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (December 21, 2023)
  • K222304 — Sonata Transcervical Fibroid Ablation System 2.2 (November 8, 2022)
  • K211535 — Sonata Transcervical Fibroid Ablation System 2.2 (June 17, 2021)
  • K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (May 4, 2020)
  • K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System (August 15, 2018)
  • K132135 — LINA GOLD LOOP HC (January 31, 2014)
  • K121343 — MODULAP LOOP (June 14, 2013)
  • K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (February 8, 2012)

FDA data resources