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510(k) K901897

ZEPPELIN FORCEPS by Kirwan Surgical Products, Inc. — Product Code HCZ

K901897 is an FDA 510(k) premarket notification submitted by Kirwan Surgical Products, Inc. for the device "ZEPPELIN FORCEPS". The FDA issued a decision of Substantially Equivalent on June 29, 1990. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Kirwan Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1990
Date Received
April 25, 1990
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 Kirwan Surgical Products, Inc.

  • K231872 — Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module ( (August 25, 2023)
  • K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULA (August 19, 2010)
  • K070360 — KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-36 (August 7, 2007)
  • K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APP (April 17, 2007)
  • K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (March 9, 2007)
  • K052203 — AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 (October 20, 2005)
  • K023482 — AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 (January 15, 2003)
  • K992218 — DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-46 (July 30, 1999)
  • K982176 — KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR (September 18, 1998)
  • K971341 — KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR (May 22, 1997)

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)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)
  • K926528 — OVUM FORCEPS (February 24, 1994)

FDA data resources