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510(k) K901896

ENDOMETRIAL SAMPLER by Kirwan Surgical Products, Inc. — Product Code EJF

K901896 is an FDA 510(k) premarket notification submitted by Kirwan Surgical Products, Inc. for the device "ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on August 13, 1990. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Kirwan Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1990
Date Received
April 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
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 EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources