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510(k) K923570

CRYOMEDICS LLETZ LOOPS by Cabot Medical Corp. — Product Code HGI

K923570 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CRYOMEDICS LLETZ LOOPS". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
July 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

Other clearances by Cabot Medical Corp.

  • K960148 — CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT (March 25, 1996)
  • K946109 — CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS (November 21, 1995)
  • K951972 — CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SH (July 21, 1995)
  • K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (July 11, 1995)
  • K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (April 19, 1995)
  • K934115 — 3000 ELECTRONIC INSUFFLATOR MODIFICATION (March 15, 1995)
  • K932293 — CABOT MEDICAL BIPOLAR CUTTING FORCEPS (July 27, 1994)
  • K930954 — THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV (June 30, 1994)
  • K932626 — CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB (June 8, 1994)
  • K935786 — CORSON AND NEZHAT SUCTION/IRRIGATION PROBES (May 19, 1994)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM (January 3, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K022593 — THOMAS MEDICAL ELECTRODES (November 1, 2002)
  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)

FDA data resources