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510(k) K952070

NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS by American Hydro-Surgical Instruments, Inc. — Product Code KNF

K952070 is an FDA 510(k) premarket notification submitted by American Hydro-Surgical Instruments, Inc. for the device "NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS". The FDA issued a decision of Substantially Equivalent on July 26, 1995. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. American Hydro-Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1995
Date Received
May 2, 1995
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 American Hydro-Surgical Instruments, Inc.

  • K953574 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER (September 29, 1995)
  • K953481 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER (August 16, 1995)
  • K946380 — NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA ( (July 6, 1995)
  • K951300 — NEZHAT-DORSEY THERMAL RETENTION SYSTEM (June 20, 1995)
  • K950499 — NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS (June 16, 1995)
  • K951119 — NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM (June 13, 1995)
  • K952421 — NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS (June 8, 1995)
  • K951733 — NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTRO (May 31, 1995)
  • K951732 — NEZHAT-DORESEY PENCIL-GRIP HANDLES (May 24, 1995)
  • K951731 — NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS (May 16, 1995)

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