Home / 510(k) Clearances / K911474

510(k) K911474

LAPAROSCOPIC FORCEPS by United States Endoscopy Group, Inc. — Product Code HCZ

K911474 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "LAPAROSCOPIC FORCEPS". The FDA issued a decision of Substantially Equivalent on July 3, 1991. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1991
Date Received
April 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Surgical, Gynecological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by United States Endoscopy Group, Inc.

  • K192265 — gi-4000 Electrosurgical Generator (May 21, 2020)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K192059 — Bio Guard Air/Water & Suction Valves (September 17, 2019)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182909 — Roth Net Retriever Product Line (November 21, 2018)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K172805 — gi-4000 Electrosurgical Generator (October 23, 2017)
  • K163495 — AdvanCE capsule endoscope delivery device (March 10, 2017)
  • K163492 — Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex (January 6, 2017)

Other clearances for product code HCZ

  • K172661 — Fetzer Medical Gynecological Forceps (May 8, 2018)
  • K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOI (April 11, 2014)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K941528 — PEARL PACKING FORCEPS (May 12, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)
  • K930039 — FORCEPS: MCGRAVEY, MCINDOE, GILLIS (February 24, 1994)

FDA data resources